Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19

NCT ID: NCT04516811

Last Updated: 2020-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2022-07-31

Brief Summary

A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19

Detailed Description

Full Title: A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19.

Short Title: PROTECT-Patient study

Aim: Assess the safety and efficacy of COVID-19 convalescent plasma (CCP) as a therapeutic treatment for hospitalised patients with moderate to severe COVID-19

Study Design: Randomised, double-blinded, placebo-controlled, phase III clinical trial

Intervention: Randomised 1:1 to either CCP plus standard of care (SOC) or to SOC plus placebo (200 mL normal saline)

Active Agent: A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines.

Placebo: A single unit of 200 mL normal saline with SOC as determined by local practice and guidelines

Sample Size: 600

Study Population: Consenting adult inpatients with moderate to severe COVID-19, not requiring invasive ventilation, who are admitted to a participating public or private sector hospital and who are not enrolled in another COVID-19 treatment trial.

Settings: Participating public and private sector hospitals in South Africa

Conditions

COVID-19; SARS-CoV-2 Infection; Severe Acute Respiratory Syndrome Coronavirus 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm 1

A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines.

Group Type: EXPERIMENTAL

COVID-19 convalescent plasma (CCP) plus standard of care (SOC)

Intervention Type: BIOLOGICAL

A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines.

Arm 2

A single unit of 200 mL normal saline with SOC as determined by local practice and guidelines.

Group Type: PLACEBO_COMPARATOR

Standard of care (SOC) plus placebo

Intervention Type: BIOLOGICAL

A single unit of 200 mL normal saline with SOC as determined by local practice and guidelines

Interventions

COVID-19 convalescent plasma (CCP) plus standard of care (SOC)

A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines.

Intervention Type: BIOLOGICAL

Standard of care (SOC) plus placebo

A single unit of 200 mL normal saline with SOC as determined by local practice and guidelines

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Laboratory confirmed SARS-CoV-2 by positive RT-PCR on any respiratory sample;
• Age ≥ 18 years;
• Require hospital admission for COVID-19 pneumonia as defined by the presence of pulmonary infiltrates on chest x-ray;
• Moderate to severe Covid-19 disease, defined as: SpO2 ≤ 93% on room air; plus requiring non-invasive oxygen therapy (WHO R&D BOSCI 4 or 5
• Signed informed consent;
• Pregnant women will be allowed to participate.

Exclusion Criteria

• Current participation in another therapeutic clinical trial for COVID-19;
• Invasive mechanical ventilation;
• Expected survival < 24 hours based on clinical assessment (however, the study does not exclude critically ill patients who are not, due to resource limitations, candidates for critical care admission and/or mechanical ventilation);
• Known hypersensitivity to immunoglobulin or any components of the formulation;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South African National Blood Service

OTHER

Sponsor Role: lead

Responsible Party

Karin van den Berg

Site Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sean Wasserman, A/Professor

Role: STUDY_CHAIR

CIDRI-Africa, University of Cape Town

Karin vandenBerg, Dr

Role: PRINCIPAL_INVESTIGATOR

South African National Blood Service

Locations

Universitas Hospital

Bloemfontein, Free State, South Africa

Site Status: NOT_YET_RECRUITING

Mitchells Plain Hospital

Cape Town, Western Cape, South Africa

Site Status: RECRUITING

Countries

South Africa

Central Contacts

Cynthia Nyoni

Role: CONTACT

Cynthia.Nyoni@sanbs.org.za

+27117619279 ext. 9279

Mpumi Maxebengula, BCom

Role: CONTACT

mpumi.maxebengula@uct.ac.za

+27214066497 ext. 6497

Facility Contacts

Jacques Malherbe

Role: primary

Sean Wasserman

Role: primary

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 32052466 (View on PubMed)

Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: RESULT

PMID: 32190290 (View on PubMed)

Other Identifiers

PROTECT-Patient trial

Identifier Type: -

Identifier Source: org_study_id