Treatment of Patients With COVID-19 With Convalescent Plasma

NCT04415086 | Completed Phase 2 DMC

• 1 other identifier: COOP-COVID-19-MCTIC
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID-19 pandemic has been spreading continuously, and in Brazil, until May 31, 2020, there have been more than 450.000 cases with more than 28.000 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of convalescent plasma in treatment of severe cases of COVID-19 in a multicenter, randomized, open-label and controlled study

Conditions

COVID-19

Keywords

COVID-19; convalescent plasma; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• Time elapsed until clinical improvement or hospital discharge

  clinical improvement is defined as the time from the randomization date until the decline of 2 categories on the ordinal scale of 10 categories or hospital discharge (whichever comes first)

  Follow up until 28 days after transfusion

Secondary Outcomes (6)

• acute adverse events

  Up to 12 hours after transfusion

• Clinical Status

  "Day 7", "Day 14" and "Day 28"

• Duration of clinical events

  Up to 28 days

• SARS-CoV-2 in nasopharyngeal swab

  Days 0, 1, 3, 7, 14 and 28 after transfusion and control groups

• IgG, IgM and IgA titers for SARS-CoV-2

  Days 0, 1, 3, 5, 7, 14 and 28 after transfusion and control groups

Study Arms (3)

Group A

SHAM COMPARATOR

Participants will receive the standard of care treatment

Biological: convalescent plasma

Group B

ACTIVE COMPARATOR

Participants will receive the standard treatment and convalescent plasma in a volume of 200ml (150-300ml)

Biological: convalescent plasma

Group C

ACTIVE COMPARATOR

Participants will receive the standard treatment and convalescent plasma in a volume of 400ml (300-600ml)

Biological: convalescent plasma

Interventions

convalescent plasma BIOLOGICAL

The study will be interrupted if the efficacy of the convalescent plasma group is proven, so that all severely ill patients as defined in the study can receive the convalescent plasma treatment. The same will occur if there is no difference in primary outcome with the use of convalescent plasma or serious adverse effects.

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age = or \> than 18 years; .
• Laboratory-proven COVID-19 infection by RT-PCR in any clinical sample . Time since symptom onset less than 10 days at the time of screening; - . Presence of COVID-19 pneumonia, with a typical, indeterminate or atypical compatible image in a chest tomography exam (see definition below) -
• Presence of one of the following criteria:
• Need for\> 3L of O2 in the catheter / mask or\> 25% in the Venturi mask to maintain O2 saturation\> 92% B presence of respiratory distress syndrome with PaO2 / FiO2 \<300mmHg If intubated, within 48 hours of orotracheal intubation
• Absence of a history of serious adverse reactions to transfusion, for example, anaphylaxis; - .Participation approval by the research clinician

You may not qualify if:

• Already enrolled in another clinical trial evaluating antiviral or immunobiological therapy for the treatment of COVID-19.
• IgA deficiency
• Presence of a clinical condition that does not allow infusion of 400 ml of volume at clinical discretion
• Pregnancy or breastfeeding
• Receipt of immunoglobulin in the last 30 days
• Presence of significant risk of death within the next 48 hours at clinical discretion.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Ministério da Ciência, Tecnologia, Inovações e Comunicações: collaborator
• Faculty of Medicine of Ribeirão Preto (FMRP-USP): collaborator
• Hospital de Clínicas, Faculdade de Medicina Universidade Estadual de Campinas: collaborator
• Hospital Sirio-Libanes: collaborator
• Hospital Israelita Albert Einstein: collaborator
• Grupo Hospitalar Conceição: collaborator
• Hospital Ernesto Dornelles: collaborator

Study Sites (1)

University of Sao Paulo - General Hospital

São Paulo, São Paulo, 01403-002, Brazil

Location

Related Publications (1)

• Song ATW, Rocha V, Mendrone-Junior A, Calado RT, De Santis GC, Benites BD, Costa-Lima C, Vargas T, Marques LS, Fernandes JC, Breda FC, Wendel S, Fachini R, Rizzo LV, Kutner JM, Avelino-Silva VI, Machado RRG, Durigon EL, Chevret S, Kallas EG. Treatment of severe COVID-19 patients with either low- or high-volume of convalescent plasma versus standard of care: A multicenter Bayesian randomized open-label clinical trial (COOP-COVID-19-MCTI). Lancet Reg Health Am. 2022 Jun;10:100216. doi: 10.1016/j.lana.2022.100216. Epub 2022 Mar 15.

  PMID: 35308034 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Esper G Kallás, PhD, MD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1:1 into 3 treatment groups: A- standard (control); B- standard and convalescent plasma in a volume of 200ml (150-300ml); C- standard and convalescent plasma in a volume of 400ml (300-600ml)

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: June 1, 2020
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: May 19, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)