Use of nMoABs for the Treatment of COVID-19 in Patients With HM.

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Completed

Conditions: Hematological Malignancy; Covid19

Study type: Observational

Funder types: Other

Identifiers

NCT04932967

EMATO0321

Details and patient eligibility

About

This is a multicenter retrospective, non-interventional observational study to evaluate the efficacy of nMoAbs in HM patients.

Full description

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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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