Use of nMoABs for the Treatment of COVID-19 in Patients With HM.
This is a multicenter retrospective, non-interventional observational study to evaluate the efficacy of nMoAbs in HM patients.
This is a multicenter retrospective, non-interventional observational study. The participating centres will retrospectively review all episodes of SARS-CoV-2 infection occurring in HMs identified at their institutions from February 2020 to May 2021 and treated with nMoAbs, to evaluate their efficacy.
Primary Outcome Measures
- time to SARS-nCov-2 test negativization [3 months]
To assess the efficacy of nMoAbs in infected HM patients compared to the historical control
- All patients must meet all the following criteria for study entry:
Age equal to or greater than 18 years of age.
Diagnosis of HM (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative disorders) at any stage/status.
Third generation rapid molecular or antigen test positive for SARS-CoV-2 from February 2020 until May 2021
Treatment with anti SARS CoV 2 nMoAbs approved by AIFA
Not hospitalized for COVID-19 at the time of nMoAbs administration
Not on oxygen therapy at the time of nMoAbs administration
At least one of the following symptoms for no more than 10 days:
Ageusia / dysgeusia
- Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable).
- Hematological diseases, other than HM.
Not tested positive for SARS-CoV-2
Patients in disease remission "off therapy" for more than 6 months
Immune plasma treatment in the previous two months
Contacts and Locations
|1||Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche||Salerno||Italy|
Sponsors and Collaborators
- Gruppo Italiano Malattie EMatologiche dell'Adulto
Study Documents (Full-Text)None provided.