Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04681430
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2020-12-17
Brief Title:
Reconvalescent PlasmaCamostat Mesylate Early in SARS-CoV-2 Q-PCR COVID-19 Positive High-risk Individuals
Sponsor:
Heinrich-Heine University Duesseldorf
Organization:
Heinrich-Heine University Duesseldorf
Study Overview
Official Title:
Reconvalescent Plasma Camostat Mesylate Early in Sars-CoV-2 Q-PCR COVID-19 Positive High-risk Individuals
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
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:
RES-Q-HR
Brief Summary:
This study is a 4-arm multicenter randomized partly double- blind controlled trial to evaluate the safety and efficacy of convalescent serum CP or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderatesevere COVID-19 The working hypothesis to be tested in the RES-Q-HR study is that the early use of convalescent plasma CP or camostat mesylate Foipan reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression The primary endpoint of the study is the cumulative number of individuals who progressed to or beyond category 4b on the modified WHO World Health Organization COVID-19 ordinal scale within 28 days after randomization
Detailed Description:
The novel coronavirus designated SARS CoV-2 and the disease caused by this virus designated COVID-19 No treatment is available for early disease stages and non-hospitalized patients to date This trial focusses on SARS-CoV-2 positive patients with pre-existing risk factors for a moderate or severe COVID-19 disease course This study is a 4-arm multicenter randomized partly double-blind controlled trial to evaluate the safety and efficacy of convalescent serum CP or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderatesevere COVID-19 Camostat mesylate acts as an inhibitor of the host cell serine protease TMPRSS2 and prevents the virus from entering the cell Convalescent plasma CP represents another antiviral strategy in terms of passive immunization The working hypothesis to be tested in the RES-Q HR study is that the early use of convalescent plasma CP or camostat mesylate Foipan reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004695-18 | EUDRACT_NUMBER | None | None |