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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-04-11

Brief Summary

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

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Detailed Description

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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.

Conditions

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Covid19 Hematological Malignancy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No