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

Covid19 Clinical Trial

Official title:

Use of Neutralizing Monoclonal Antibodies for the Treatment of COVID-19 in Patients With Hematological Malignancies (SIE-GIMEMA Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04932967
• Other study ID #: EMATO0321
• Status: Completed
• Start date: September 30, 2021
• Est. completion date: April 11, 2022

Study information

• Verified date: June 2022
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: April 11, 2022
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Hematologic Neoplasms
• Hematological Malignancy
• Neoplasms

Locations

Country	Name	City	State
Italy	Aou Consorziale Policlinico - Uo Ematologia Con Trapianto	Bari
Italy	Asst Degli Spedali Civili Di Brescia	Brescia
Italy	Ospedale Valduce - Uos Ematologia	Como
Italy	Aou Careggi	Firenze
Italy	Irccs Aou San Martino	Genova
Italy	Fondazione Irccs "Istituto Nazionale Tumori"	Milano
Italy	Aou Maggiore Della Carità Di Novara	Novara
Italy	AOU Padova	Padova
Italy	Aou Pisana - Uo Ematologia Universitaria	Pisa
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	Aou Senese	Siena
Italy	Asui Di Udine, Presidio Ou "S. Maria Della Misericordia"	Udine
Italy	Asst Dei Sette Laghi, Ospedale Di Circolo E Fondazione Macchi	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to SARS-nCov-2 test negativization	To assess the efficacy of nMoAbs in infected HM patients compared to the historical control	3 months