Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT04932967
Eligibility Criteria:
Inclusion Criteria:
* All patients must meet all the following criteria for study entry:
1. Age equal to or greater than 18 years of age.
2. Diagnosis of HM (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative disorders) at any stage/status.
3. Third generation rapid molecular or antigen test positive for SARS-CoV-2 from February 2020 until May 2021
4. Treatment with anti SARS CoV 2 nMoAbs approved by AIFA
5. Not hospitalized for COVID-19 at the time of nMoAbs administration
6. Not on oxygen therapy at the time of nMoAbs administration
7. At least one of the following symptoms for no more than 10 days:
* Fever
* Cough
* Anosmia
* Ageusia / dysgeusia
* Pharyngodynia
* Asthenia
* Headache
* Nausea
* Diarrhea
* Myalgia
* Dyspnea
* Tachypnea
8. Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable).
Exclusion Criteria:
* 1\. Hematological diseases, other than HM.
2\. Not tested positive for SARS-CoV-2
3\. Patients in disease remission "off therapy" for more than 6 months
4\. Immune plasma treatment in the previous two months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04932967
Study Brief:
Protocol Section:
NCT04932967