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

Completed

• Conditions: Hematological Malignancy; Covid19

• Registration Number: NCT04932967
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-21
• Study Start: 2021-09-30
• Primary Completion: 2022-04-11
• Study Completion: 2022-04-11
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
time to SARS-nCov-2 test negativization	3 months	To assess the efficacy of nMoAbs in infected HM patients compared to the historical control

Trial Locations

Locations (14)

Irccs Aou San Martino; 🇮🇹 Genova, Italy

Aou Pisana - Uo Ematologia Universitaria; 🇮🇹 Pisa, Italy

Ospedale Valduce - Uos Ematologia; 🇮🇹 Como, Italy

Asst Degli Spedali Civili Di Brescia; 🇮🇹 Brescia, Italy

Aou Consorziale Policlinico - Uo Ematologia Con Trapianto; 🇮🇹 Bari, Italy

AOU Padova; 🇮🇹 Padova, Italy

Fondazione Irccs "Istituto Nazionale Tumori"; 🇮🇹 Milano, Italy

Aou Careggi; 🇮🇹 Firenze, Italy

Aou Maggiore Della Carità Di Novara; 🇮🇹 Novara, Italy

Fondazione Policlinico Universitario Agostino Gemelli-Irccs; 🇮🇹 Roma, Italy

Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche; 🇮🇹 Salerno, Italy

Asui Di Udine, Presidio Ou "S. Maria Della Misericordia"; 🇮🇹 Udine, Italy

Aou Senese; 🇮🇹 Siena, Italy

Asst Dei Sette Laghi, Ospedale Di Circolo E Fondazione Macchi; 🇮🇹 Varese, Italy