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Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease (PC-COVID-HCM)

Primary Purpose

Severe COVID-19 Disease

Status

Completed

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

Biological

About this trial

This is an interventional treatment trial for Severe COVID-19 Disease focused on measuring SARS-CoV2, Convalescent Plasma, Severe Acute Respiratory Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

O2 saturation <93%
Radiographic evidence of moderate pneumonia according to Rale's classification.
Acute respiratory distress syndrome (PaO2 / FiO2 <300 or SpO2 / FiO2 ≤ 315)
Authorization to participate in the study and have informed consent letter, signed by the patient or the person responsible for the patient in case of critical patients (intubated)

Exclusion Criteria:

Pregnant patients
History of transfusion reactions
Patients with congestive heart failure
Patients with a history of chronic kidney failure on dialysis
Patients with multiple organ failure
Patients who does not accept or agree with the treatment.

Sites / Locations

Hospital Central Militar

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Convalescent plasma group.

Arm Description

They will receive the standard care for critically ill inpatients.

They will receive standard care for patients with severe COVID-19 disease and convalescent plasma disease.

Outcomes

Primary Outcome Measures

Disease progression

Change in ordinal Scale for Clinical Improvement (WHO). The progression disease, its the change in the severity score; a bigger number to the obtained after randomization

Side effects

Side effects associated with the administration of convalescent plasma

Mortality

Any cause of death

Secondary Outcome Measures

Respiratory improvement

Change in partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio (PaO2/FiO2)

Clinical improvement

Change in oxygen saturation levels

Acute adverse events (AAE)

Transfusion reactions during transfusion.

Full Information

NCT ID

NCT04542967

First Posted

September 4, 2020

Last Updated

May 6, 2021

Sponsor

Hospital Central Militar

1. Study Identification

Unique Protocol Identification Number

NCT04542967

Brief Title

Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease

Acronym

PC-COVID-HCM

Official Title

Convalescent Plasma as a Treatment for Patients With Severe COVID-19 Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

June 23, 2020 (Actual)

Primary Completion Date

September 2, 2020 (Actual)

Study Completion Date

September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Central Militar

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Currently, there is no specific treatment or vaccine for SARS-CoV-2 available, some drugs are being investigated as treatment, but the effect is unknown. A strategy and other method used before, in coronavirus pandemic (SARS-CoV in 2003 and MERS-CoV in 2012), was the use of immune (convalescent) plasma. Passive administration of antibodies through convalescent plasma transfusion may offer the only short-term strategy available to confer immediate immunity and being a relative immediately resource available for treat COVID-19 disease. This research proposes the passive administration of antibodies through the transfusion of convalescent plasma, in patients with severe COVID-19 disease.

Detailed Description

A randomized clinical trial comparing administration convalescent plasma to standard therapy for severe COVID-19 disease. Patients will be randomized 1:1 in a single blind study. The patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. Our primary outcomes will be disease progression and mortality, evaluate of ordinal Scale for Clinical Improvement and. (WHO)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe COVID-19 Disease

Keywords

SARS-CoV2, Convalescent Plasma, Severe Acute Respiratory Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

The PC-COVID-HCM clinical trial is a randomized, controlled, single-blind study .

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The research was blinded as possible for the result's evaluators and those responsible for the statistical analysis. All patients admitted to the investigation were placed with a marker indicating that they were a patient of the plasma protocol, but not mention the study group. The data collectors and the outcome adjudicators were unaware of the treatment assignments.

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

No Intervention

Arm Description

They will receive the standard care for critically ill inpatients.

Arm Title

Convalescent plasma group.

Arm Type

Experimental

Arm Description

They will receive standard care for patients with severe COVID-19 disease and convalescent plasma disease.

Intervention Type

Biological

Intervention Name(s)

Biological

Other Intervention Name(s)

Convalescent plasma

Intervention Description

An administration unit of 200 ml convalescent plasma intravenous infusion every 24 hours for two doses. If a third dose of convalescent plasma is necessary, it may be used, as long as an evaluation of the research team is carried out.

Primary Outcome Measure Information:

Title

Disease progression

Description

Change in ordinal Scale for Clinical Improvement (WHO). The progression disease, its the change in the severity score; a bigger number to the obtained after randomization

Time Frame

Up to 30 days later from study entry

Title

Side effects

Description

Side effects associated with the administration of convalescent plasma

Time Frame

Up to 30 days later from study entry

Title

Mortality

Description

Any cause of death

Time Frame

Up to 30 days later from study entry

Secondary Outcome Measure Information:

Title

Respiratory improvement

Description

Change in partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio (PaO2/FiO2)

Time Frame

10 days

Title

Clinical improvement

Description

Change in oxygen saturation levels

Time Frame

10 days

Title

Acute adverse events (AAE)

Description

Transfusion reactions during transfusion.

Time Frame

After receiving intervention, an average time one hour, until 24 hours after administration.

Other Pre-specified Outcome Measures:

Title

Inflammatory biomarkers (D dimer)

Description

Change in pro-inflammatory biomarkers (D dimer μg/l)

Time Frame

10 days

Title

Inflammatory biomarkers (Ferritin)

Description

Change in pro-inflammatory biomarkers ( Ferritin μg/L )

Time Frame

10 days

Title

Inflammatory biomarkers (CPR)

Description

Change in pro-inflammatory biomarkers, C-reactive protein ( CPR mg/L )

Time Frame

10 days

Title

Inflammatory biomarkers (LDH)

Description

Change in pro-inflammatory biomarkers, lactate dehydrogenase ( LDH UI/L)

Time Frame

10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: O2 saturation <93% Radiographic evidence of moderate pneumonia according to Rale's classification. Acute respiratory distress syndrome (PaO2 / FiO2 <300 or SpO2 / FiO2 ≤ 315) Authorization to participate in the study and have informed consent letter, signed by the patient or the person responsible for the patient in case of critical patients (intubated) Exclusion Criteria: Pregnant patients History of transfusion reactions Patients with congestive heart failure Patients with a history of chronic kidney failure on dialysis Patients with multiple organ failure Patients who does not accept or agree with the treatment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carmen G Torres, MD

Organizational Affiliation

Hospital Central Militar

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Central Militar

City

Mexico City

ZIP/Postal Code

11200

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Plan to make IPD still not decided and would need approval by regulatory authorities

IPD Sharing Time Frame

From 6 months after publication

IPD Sharing Access Criteria

PRIOR APPLICATION

Links:

URL

http://pubmed.ncbi.nlm.nih.gov/32109013/

Description

Clinical Characteristics of Coronavirus Disease 2019 in China

URL

http://pubmed.ncbi.nlm.nih.gov/32052466/

Description

Potential interventions for novel coronavirus in China: A systematic review

URL

http://pubmed.ncbi.nlm.nih.gov/15616839/

Description

Use of convalescent plasma therapy in SARS patients in Hong Kong

Learn more about this trial

Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease

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