Clinical trial NCT04932967: Use of nMoABs for the Treatment of COVID-19 in Patients With HM.
Official title: Use of Neutralizing Monoclonal Antibodies for the Treatment of COVID-19 in Patients With Hematological Malignancies (SIE-GIMEMA Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Hematological Malignancy
Keywords: Neutralizing Monoclonal Antibodies
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients older than 18 years of age with HM who received nMoAbs, approved by AIFA, for the treatment of SARS-CoV-2 infection.

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.

Eligibility criteria: 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

Primary outcomes:
measure: time to SARS-nCov-2 test negativization
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Aou Consorziale Policlinico - Uo Ematologia Con Trapianto
city: Brescia
country: Italy
facility: Asst Degli Spedali Civili Di Brescia
city: Como
country: Italy
facility: Ospedale Valduce - Uos Ematologia
city: Firenze
country: Italy
facility: Aou Careggi
city: Genova
country: Italy
facility: Irccs Aou San Martino
city: Milano
country: Italy
facility: Fondazione Irccs "Istituto Nazionale Tumori"
city: Novara
country: Italy
facility: Aou Maggiore Della Carità Di Novara
city: Padova
country: Italy
facility: AOU Padova
city: Pisa
country: Italy
facility: Aou Pisana - Uo Ematologia Universitaria
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli-Irccs
city: Salerno
country: Italy
facility: Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
city: Siena
country: Italy
facility: Aou Senese
city: Udine
country: Italy
facility: Asui Di Udine, Presidio Ou "S. Maria Della Misericordia"
city: Varese
country: Italy
facility: Asst Dei Sette Laghi, Ospedale Di Circolo E Fondazione Macchi
Study officials:
References:
citation: Marasco V, Piciocchi A, Candoni A, Pagano L, Guidetti A, Musto P, Bruna R, Bocchia M, Visentin A, Turrini M, Tucci A, Pilerci S, Fianchi L, Salvini M, Galimberti S, Coviello E, Selleri C, Luppi M, Crea E, Fazi P, Passamonti F, Corradini P. Neutralizing monoclonal antibodies in haematological patients paucisymptomatic for COVID-19: The GIMEMA EMATO-0321 study. Br J Haematol. 2022 Oct;199(1):54-60. doi: 10.1111/bjh.18385. Epub 2022 Jul 30.