Ignite Creation Date:
2024-05-06 @ 2:43 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04402203
Status:
UNKNOWN
Last Update Posted:
2020-05-26
First Post:
2020-05-19
Brief Title:
Study on Safety and Efficacy of Favipiravir Favipira for COVID-19 Patient in Selected Hospitals of Bangladesh
Sponsor:
Bangladesh Medical Research Council BMRC
Organization:
Bangladesh Medical Research Council BMRC
Study Overview
Official Title:
Study on Safety and Efficacy of Favipiravir Favipira for COVID-19 Patient in Selected Hospitals of Bangladesh
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A recent outbreak of coronavirus disease 2019 COVID-19 caused by the novel coronavirus designated as severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 started in Wuhan China at the end of 2019 The clinical characteristics of COVID-19 include respiratory symptoms fever cough dyspnea and pneumonia As of 25 February 2020 at least 77 785 cases and 2666 deaths had been identified across China and in other countries in particular 977 and 861 cases were identified in South Korea and Japan respectively The outbreak has already caused global alarm On 30 January 2020 the World Health Organization WHO declared that the outbreak of SARS-CoV-2 constituted a Public Health Emergency of International Concern PHEIC and issued advice in the form of temporary recommendations under the International Health Regulations IHRIt has been revealed that SARS-CoV-2 has a genome sequence that is 75-80 identical to that of SARS-CoV and has more similarities to several bat coronaviruses SARS-CoV-2 is the seventh reported human-infecting member of the family Coronaviridae which also includes SARS-CoV and the Middle East respiratory syndrome MERS-CoV It has been identified as the causative agent of COVID-19 Both the clinical and the epidemiological features of COVID-19 patients demonstrate that SARS-CoV-2 infection can lead to intensive care unit ICU admission and high mortality About 16-21 of people with the virus in China have become severely ill with a 2-3 mortality rate However there is no specific treatment against the new virus
Therefore it is urgently necessary to identify effective antiviral agents to combat the disease and explore the clinical effect of antiviral drugs One efficient approach to discover effective drugs is to test whether the existing antiviral drugs are effective in treating other related viral infections Several drugs such as ribavirin interferon IFN Favipiravir FPV and Lopinavir LPVritonavir RTV have been used in patients with SARS or MERS although the efficacy of some drugs remains controversial It has recently been demonstrated that as a prodrug Favipiravir half maximal effective concentration EC50 6188 μmolL-1 half-maximal cytotoxic concentration CC50 400 μmolL-1 selectivity index SI 646 effectively inhibits the SARS-CoV-2 infection in Vero E6 cells ATCC-1586 Furthermore other reports show that FPV is effective in protecting mice against Ebola virus challenge although its EC50 value in Vero E6 cells was as high as 67 μmolL-1 Therefore clinical studies are urgently needed to evaluate the efficacy and safety of this antiviral nucleoside for COVID-19 treatment After enrollment of the patients day 1 depending on inclusion and exclusion criteria and laboratory findings confirming the presence of the COVID-19 virus 25 patients will receive Favipiravir plus standard treatment and the second group of 25 patients will receive standard treatment only The comparison of the findings of the follow up studies on days 4 7 and 10 in terms of clinical manifestations chest X-ray and laboratory findings such as Real Time Polymerase Chain Reaction RT-PCR results for viral presence will determine whether Favipiravir has safety and efficacy against COVID-19 infections
All ethical issues related to this trial including right of the participants to withdraw from the study should be maintained according to of guidelines of International Conference on Harmonisation ICH-Good Clinical Practice GCP
Therefore it is urgently necessary to identify effective antiviral agents to combat the disease and explore the clinical effect of antiviral drugs One efficient approach to discover effective drugs is to test whether the existing antiviral drugs are effective in treating other related viral infections Several drugs such as ribavirin interferon IFN Favipiravir FPV and Lopinavir LPVritonavir RTV have been used in patients with SARS or MERS although the efficacy of some drugs remains controversial It has recently been demonstrated that as a prodrug Favipiravir half maximal effective concentration EC50 6188 μmolL-1 half-maximal cytotoxic concentration CC50 400 μmolL-1 selectivity index SI 646 effectively inhibits the SARS-CoV-2 infection in Vero E6 cells ATCC-1586 Furthermore other reports show that FPV is effective in protecting mice against Ebola virus challenge although its EC50 value in Vero E6 cells was as high as 67 μmolL-1 Therefore clinical studies are urgently needed to evaluate the efficacy and safety of this antiviral nucleoside for COVID-19 treatment After enrollment of the patients day 1 depending on inclusion and exclusion criteria and laboratory findings confirming the presence of the COVID-19 virus 25 patients will receive Favipiravir plus standard treatment and the second group of 25 patients will receive standard treatment only The comparison of the findings of the follow up studies on days 4 7 and 10 in terms of clinical manifestations chest X-ray and laboratory findings such as Real Time Polymerase Chain Reaction RT-PCR results for viral presence will determine whether Favipiravir has safety and efficacy against COVID-19 infections
All ethical issues related to this trial including right of the participants to withdraw from the study should be maintained according to of guidelines of International Conference on Harmonisation ICH-Good Clinical Practice GCP
Detailed Description:
Rationale Coronavirus disease 2019 COVID-19 is defined as illness caused by a novel coronavirus now called severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 formerly called 2019-nCoV which was first identified amid an outbreak of respiratory illness cases in Wuhan City Hubei Province China It was initially reported to the World Health Organization WHO on December 31 2019 On January 30 2020 the WHO declared the COVID-19 outbreak a global health emergency On March 11 2020 the WHO declared COVID-19 a global pandemic its first such designation since declaring influenza A virus subtype H1N1 influenza a pandemic in 2009 No drugs or biologics have been proven to be effective for the prevention or treatment of COVID-19 Numerous antiviral agents immunotherapies and vaccines are being investigated and developed as potential therapies Fujifilm Toyama Chemical has started a Phase III clinical trial of its antiviral influenza drug Avigan favipiravir for the treatment of Covid-19 patients in Japan Avigan specifically blocks RNA polymerase associated with influenza viral replication The mechanism is expected to have an antiviral effect on SARS-CoV-2 the novel coronavirus that causes Covid-19 In Japan the new Phase III trial will assess Avigans safety and efficacy as a potential Covid-19 treatment Last month Chinas Science and Technology Ministry official Zhang Xinmin said that favipiravir helped patients recover in an 80-day participant trial conducted in Shenzhen city
According to the study data the drug was able to shorten the recovery time from 11 days to four days for mild and moderate cases Favipiravir secured Chinese approval for manufacturing by Zhejiang Hisun Pharmaceutical to treat adults with new or recurring influenza It also holds approval in China as an investigational treatment for Covid-19 A drug developed by Fujifilm Toyama Chemical in Japan is showing promising outcomes in treating at least mild to moderate cases of COVID-19 Live Science previously reported The antiviral drug called Favipiravir or Avigan has been used in Japan to treat influenza and last month the drug was approved as an experimental treatment for COVID-19 infection The drug which works by preventing certain viruses from replicating seemed to shorten the duration of the virus as well as improve lung conditions as seen in X-rays in tested patients
A few studies have been published in international journals regarding the efficacy and safety of Favipiravir However this type of study on Favipiravir Favipira has not yet been done in our country This is the rationale why we have designed this clinical trial in Bangladesh to fight against COVID-19 a global pandemic
Objectives
General Objectives
To evaluate the efficacy and safety of Favipiravir Favipira for the treatment of COVID-19 in a group of Bangladeshi patients
Specific objectives
Primary end point
To assess the treatment efficacy Negative for the virus at 4-10 days after initiation of therapy However negative results for the viral presence should be with an interval of at least 24 hours
To assess the treatment efficacy X-ray findings of lung condition improvement at Day-4 Day-7 and Day-10 of therapy
Secondary end point
Clinical recovery rate at 7-10 days of therapy and reduced duration of fever cough relief time auxiliary oxygen therapy or noninvasive mechanical ventilation rate
To assess the adverse effects of drug
ICU admission rate
Mortality rate
Hypothesis
Favipiravir might be an effective drug for the treatment of COVID-19
Methodology
Study design Double-blind placebo-controlled randomized control study Randomization will be done by computerized randomization table
Place of study Mahanagar General Hospital Dhaka Site-1 Mugda Medical College Hospital Dhaka Site-2 Kurmitola General Hospital Dhaka Site-3 Dhaka Medical College Hospital Dhaka Site-4
Duration of study 2 months
Study population Clinically and Laboratory-confirmed patients with COVID-19
Formulae
Variable Notations
Α the probability of type I error significance level is the probability of rejecting the true null hypothesis 005 Β the probability of type II error 1 - power of the test is the probability of failing to reject the false null hypothesis 080
PA proportion of discordant pairs of type A among discordant pairs 14 PD proportion of discordant pairs among all pairs 025 Npairs required sample size pair 25250 A matched-pair design is used in which patients are matched on age and clinical stage of COVID-19 with one patient in a matched pair assigned to treatment case and the other to treatment control It is estimated that patients in a matched pair will respond similarly to the treatments in 85 of matched pairs How many matched pairs need to be enrolled in the study to have a 90 chance of finding a significant difference using a two-sided test with type I error 005 So we will recruit a total of 50 patients
Randomization will be done by computerized randomization table Group A Patient 25 Favipiravir Standard Treatment Group B Patient 25 Only Standard Treatment For better result sample size may be multiply on the basis of availability of COVID-19 patient in the study hospital
Diagnostic Criteria
All patients diagnosed as COVID-19 positive on the basis of clinical and Laboratory findings If the respiratory specimens give positive results upon RT-PCR analysis at the lab targeting conserved viral genes such as E gene and or RNA-dependent RNA polymerase RdRp gene or other COVID-19 specific genes it will be considered as confirmed positive case for COVID-19
Data Collection Procedure
Patient admitted in Isolation ward with COVID-19 positive will be used Study population again will be confirmed by laboratory findings Patients will be selected for the study following inclusion and exclusion criteria Written consent will be taken from the patient for treatment with Favipiravir After data collection data will be analyzed for result Finally Summary and conclusion will be published
Background of Data Collectors at the clinical sites
Data will be collected by Co-investigators of the study who are employed as physicians in the Isolation word for COVID-19 positive patients in the designated hospitals Co-investigators are familiar about the data collection procedure as per clinical trial protocol
Precaution and safety of the Data Collectors including physicians laboratory personnel nurses and medical technologists
Data Collectors should fill up data collection sheet properly Proper monitoring of the patient should be carefully done
Data collectors must wear appropriate personal protective equipment PPE including gown N95 mask hand gloves head coverings and goggles to protect themselves I case anyone involved in the study get infected heshe should be sent to the designated isolation unitquarantine to mitigate spread of the disease and get treatment
Treatment
Favipiravir 200 mg Favipira tablet will be given orally Day 1 Tablet Favipiravir 1600 mg twice daily Days 2-Days 10 Tablet Favipiravir 600 mg twice daily Group A Patient 25 Favipiravir Standard Treatment Group B Patient 25 Only Standard Treatment
Standard treatment included oxygen inhalation oral or intravenous rehydration electrolyte correction antipyretics analgesics antibiotics and antiemetic drugs the medication any patient is on due to any concomitant diseases
Management of adverse events
It has been suggested that host cell enzymes cellular kinases convert Favipiravir into Favipiravir ribofuranosyl phosphate a form that inhibits virus polymerase without affecting host cellular RNA or DNA synthesis Research documents indicate that Favipiravir is a well-tolerated drug with some side effects like headache nausea and hypersensivity On prolong treatment it may develop inflammation of liver and kidney abortion intrauterine fetal death and congenital anomalies of newborn baby
Considering the longterm effects of Favipiravir patients with Chronic liver and kidney disease previous history of allergic reactions to Favipiravir Pregnant or lactating women Women of a childbearing age with a positive pregnancy test and having history of Miscarriage or within 2 weeks after delivery have been excluded in the study proposal
Management of side effects like headache nausea and hypersensitivity will counter at the early stage of onset and all medicines and instruments will be kept available at the ward near the patient bed for prompt management during treatment with Favipiravir
Any adverse or side effect will be managed immediately with standard treatment procedure with discontinuation of the test drug Research physicians under the supervision of Clinical Trial Monitors will monitor clinically all the vital signs along with adverse symptoms if any arise routinely and be available for taking measures against any side or adverse effect They will record all the events clinically along with the routine data collection
For any occurrence due mismanagement with the side effects of Favipiravir the entire research team will be responsible
Adverse Drug Reaction Reporting time
If any adverse drug reaction occurs during study period it should be reported within 24 hours of the event to the Data Safety and Monitoring Board DSMB in order to assess the risk and quick action should be taken
Laboratory data collection Blood and respiratory samples will be collected by trained medical technologist and transported immediately to Institute for developing Science and Health initiatives ideSHi for analysis Cool chain will be maintained during sample transportation Blood sample analysis at the laboratory will be done by trained research officers and fellows On the other hand RT-PCR using respiratory samples for viral detection will be done by expert molecular biologist
Follow-up System
Baseline clinical symptoms and Laboratory findings will be monitored from first day and follow up will be continued at Day-4 Day-7 and Day-10 Viral clearance will be checked by RT-PCR at Day-4 Day-7 and Day-10 X-ray findings will be monitored from Day-1 followed by Day-4 Day-7 and Day-10 to see the lung condition Any Side effects of drugs will be documented
Statistical Analysis
All data will be analyzed by using the statistical package for social science SPSS 22 All data will be provided as mean standard deviation SD Chi-square test will be used to compare differences between the frequencies Serum cytokines levels will be analyzed using the normality test P value 005 will be considered significant
Utilization of Results
A recent outbreak of coronavirus disease 2019 COVID-19 caused by the novel coronavirus designated as severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 started in Wuhan China at the end of 2019 The clinical characteristics of COVID-19 include respiratory symptoms fever cough dyspnea and pneumonia According to world health organization WHO COVID-19 updates on 10th April 2020 globally confirmed cases were 1617204 confirmed deaths were 97039 recovered 364686 peoples In Bangladesh confirmed cases were 424 confirmed deaths were 27 recovered 33 peoples
No drugs or biologics have been proven to be effective for the prevention or treatment of COVID-19 Numerous antiviral agents immunotherapies and vaccines are being investigated and developed as potential therapies A drug developed by Fujifilm Toyama Chemical in Japan is showing promising outcomes in treating at least mild to moderate cases of COVID-19 Live Science previously reported The antiviral drug called Favipiravir or Avigan has been used in Japan to treat influenza and last month the drug was approved as an experimental treatment for COVID-19 infection The drug which works by preventing certain viruses from replicating seemed to shorten the duration of the virus as well as improve lung conditions as seen in X-rays in tested patientsIn our study on Favipiravir Favipira if we will get promising result regarding efficacy and safety then it saves thousands life of Bangladeshi people We may also export the Medicine across the globe to fight against COVID-19 a global pandemic
Facilities Kurmitola General Hospital and Kuwait Bangladesh Maitry Govt Hospital both Hospitals are Bangladesh Govt approved hospital for COVID-19 treatment So almost all facilities will be available
Ethical Implications
Permission will be taken from Bangladesh Medical Research Council and The Directorate General of Drug Administration DGDA for conducting this study
Before data collection objective of the study will be informed to the respondent
Informed written consent will be obtained from the participants of the study
The privacy and confidentiality will strictly be maintained during data collection
Right to discontinue from the study at any time will be ensured
Any adverse or side effect will be managed immediately with standard treatment procedure with discontinuation of the test drug
According to the study data the drug was able to shorten the recovery time from 11 days to four days for mild and moderate cases Favipiravir secured Chinese approval for manufacturing by Zhejiang Hisun Pharmaceutical to treat adults with new or recurring influenza It also holds approval in China as an investigational treatment for Covid-19 A drug developed by Fujifilm Toyama Chemical in Japan is showing promising outcomes in treating at least mild to moderate cases of COVID-19 Live Science previously reported The antiviral drug called Favipiravir or Avigan has been used in Japan to treat influenza and last month the drug was approved as an experimental treatment for COVID-19 infection The drug which works by preventing certain viruses from replicating seemed to shorten the duration of the virus as well as improve lung conditions as seen in X-rays in tested patients
A few studies have been published in international journals regarding the efficacy and safety of Favipiravir However this type of study on Favipiravir Favipira has not yet been done in our country This is the rationale why we have designed this clinical trial in Bangladesh to fight against COVID-19 a global pandemic
Objectives
General Objectives
To evaluate the efficacy and safety of Favipiravir Favipira for the treatment of COVID-19 in a group of Bangladeshi patients
Specific objectives
Primary end point
To assess the treatment efficacy Negative for the virus at 4-10 days after initiation of therapy However negative results for the viral presence should be with an interval of at least 24 hours
To assess the treatment efficacy X-ray findings of lung condition improvement at Day-4 Day-7 and Day-10 of therapy
Secondary end point
Clinical recovery rate at 7-10 days of therapy and reduced duration of fever cough relief time auxiliary oxygen therapy or noninvasive mechanical ventilation rate
To assess the adverse effects of drug
ICU admission rate
Mortality rate
Hypothesis
Favipiravir might be an effective drug for the treatment of COVID-19
Methodology
Study design Double-blind placebo-controlled randomized control study Randomization will be done by computerized randomization table
Place of study Mahanagar General Hospital Dhaka Site-1 Mugda Medical College Hospital Dhaka Site-2 Kurmitola General Hospital Dhaka Site-3 Dhaka Medical College Hospital Dhaka Site-4
Duration of study 2 months
Study population Clinically and Laboratory-confirmed patients with COVID-19
Formulae
Variable Notations
Α the probability of type I error significance level is the probability of rejecting the true null hypothesis 005 Β the probability of type II error 1 - power of the test is the probability of failing to reject the false null hypothesis 080
PA proportion of discordant pairs of type A among discordant pairs 14 PD proportion of discordant pairs among all pairs 025 Npairs required sample size pair 25250 A matched-pair design is used in which patients are matched on age and clinical stage of COVID-19 with one patient in a matched pair assigned to treatment case and the other to treatment control It is estimated that patients in a matched pair will respond similarly to the treatments in 85 of matched pairs How many matched pairs need to be enrolled in the study to have a 90 chance of finding a significant difference using a two-sided test with type I error 005 So we will recruit a total of 50 patients
Randomization will be done by computerized randomization table Group A Patient 25 Favipiravir Standard Treatment Group B Patient 25 Only Standard Treatment For better result sample size may be multiply on the basis of availability of COVID-19 patient in the study hospital
Diagnostic Criteria
All patients diagnosed as COVID-19 positive on the basis of clinical and Laboratory findings If the respiratory specimens give positive results upon RT-PCR analysis at the lab targeting conserved viral genes such as E gene and or RNA-dependent RNA polymerase RdRp gene or other COVID-19 specific genes it will be considered as confirmed positive case for COVID-19
Data Collection Procedure
Patient admitted in Isolation ward with COVID-19 positive will be used Study population again will be confirmed by laboratory findings Patients will be selected for the study following inclusion and exclusion criteria Written consent will be taken from the patient for treatment with Favipiravir After data collection data will be analyzed for result Finally Summary and conclusion will be published
Background of Data Collectors at the clinical sites
Data will be collected by Co-investigators of the study who are employed as physicians in the Isolation word for COVID-19 positive patients in the designated hospitals Co-investigators are familiar about the data collection procedure as per clinical trial protocol
Precaution and safety of the Data Collectors including physicians laboratory personnel nurses and medical technologists
Data Collectors should fill up data collection sheet properly Proper monitoring of the patient should be carefully done
Data collectors must wear appropriate personal protective equipment PPE including gown N95 mask hand gloves head coverings and goggles to protect themselves I case anyone involved in the study get infected heshe should be sent to the designated isolation unitquarantine to mitigate spread of the disease and get treatment
Treatment
Favipiravir 200 mg Favipira tablet will be given orally Day 1 Tablet Favipiravir 1600 mg twice daily Days 2-Days 10 Tablet Favipiravir 600 mg twice daily Group A Patient 25 Favipiravir Standard Treatment Group B Patient 25 Only Standard Treatment
Standard treatment included oxygen inhalation oral or intravenous rehydration electrolyte correction antipyretics analgesics antibiotics and antiemetic drugs the medication any patient is on due to any concomitant diseases
Management of adverse events
It has been suggested that host cell enzymes cellular kinases convert Favipiravir into Favipiravir ribofuranosyl phosphate a form that inhibits virus polymerase without affecting host cellular RNA or DNA synthesis Research documents indicate that Favipiravir is a well-tolerated drug with some side effects like headache nausea and hypersensivity On prolong treatment it may develop inflammation of liver and kidney abortion intrauterine fetal death and congenital anomalies of newborn baby
Considering the longterm effects of Favipiravir patients with Chronic liver and kidney disease previous history of allergic reactions to Favipiravir Pregnant or lactating women Women of a childbearing age with a positive pregnancy test and having history of Miscarriage or within 2 weeks after delivery have been excluded in the study proposal
Management of side effects like headache nausea and hypersensitivity will counter at the early stage of onset and all medicines and instruments will be kept available at the ward near the patient bed for prompt management during treatment with Favipiravir
Any adverse or side effect will be managed immediately with standard treatment procedure with discontinuation of the test drug Research physicians under the supervision of Clinical Trial Monitors will monitor clinically all the vital signs along with adverse symptoms if any arise routinely and be available for taking measures against any side or adverse effect They will record all the events clinically along with the routine data collection
For any occurrence due mismanagement with the side effects of Favipiravir the entire research team will be responsible
Adverse Drug Reaction Reporting time
If any adverse drug reaction occurs during study period it should be reported within 24 hours of the event to the Data Safety and Monitoring Board DSMB in order to assess the risk and quick action should be taken
Laboratory data collection Blood and respiratory samples will be collected by trained medical technologist and transported immediately to Institute for developing Science and Health initiatives ideSHi for analysis Cool chain will be maintained during sample transportation Blood sample analysis at the laboratory will be done by trained research officers and fellows On the other hand RT-PCR using respiratory samples for viral detection will be done by expert molecular biologist
Follow-up System
Baseline clinical symptoms and Laboratory findings will be monitored from first day and follow up will be continued at Day-4 Day-7 and Day-10 Viral clearance will be checked by RT-PCR at Day-4 Day-7 and Day-10 X-ray findings will be monitored from Day-1 followed by Day-4 Day-7 and Day-10 to see the lung condition Any Side effects of drugs will be documented
Statistical Analysis
All data will be analyzed by using the statistical package for social science SPSS 22 All data will be provided as mean standard deviation SD Chi-square test will be used to compare differences between the frequencies Serum cytokines levels will be analyzed using the normality test P value 005 will be considered significant
Utilization of Results
A recent outbreak of coronavirus disease 2019 COVID-19 caused by the novel coronavirus designated as severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 started in Wuhan China at the end of 2019 The clinical characteristics of COVID-19 include respiratory symptoms fever cough dyspnea and pneumonia According to world health organization WHO COVID-19 updates on 10th April 2020 globally confirmed cases were 1617204 confirmed deaths were 97039 recovered 364686 peoples In Bangladesh confirmed cases were 424 confirmed deaths were 27 recovered 33 peoples
No drugs or biologics have been proven to be effective for the prevention or treatment of COVID-19 Numerous antiviral agents immunotherapies and vaccines are being investigated and developed as potential therapies A drug developed by Fujifilm Toyama Chemical in Japan is showing promising outcomes in treating at least mild to moderate cases of COVID-19 Live Science previously reported The antiviral drug called Favipiravir or Avigan has been used in Japan to treat influenza and last month the drug was approved as an experimental treatment for COVID-19 infection The drug which works by preventing certain viruses from replicating seemed to shorten the duration of the virus as well as improve lung conditions as seen in X-rays in tested patientsIn our study on Favipiravir Favipira if we will get promising result regarding efficacy and safety then it saves thousands life of Bangladeshi people We may also export the Medicine across the globe to fight against COVID-19 a global pandemic
Facilities Kurmitola General Hospital and Kuwait Bangladesh Maitry Govt Hospital both Hospitals are Bangladesh Govt approved hospital for COVID-19 treatment So almost all facilities will be available
Ethical Implications
Permission will be taken from Bangladesh Medical Research Council and The Directorate General of Drug Administration DGDA for conducting this study
Before data collection objective of the study will be informed to the respondent
Informed written consent will be obtained from the participants of the study
The privacy and confidentiality will strictly be maintained during data collection
Right to discontinue from the study at any time will be ensured
Any adverse or side effect will be managed immediately with standard treatment procedure with discontinuation of the test drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None