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

NCT04516811 | Terminated Phase 3 DMC

• 1 other identifier: PROTECT-Patient trial
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Clinical Improvement

  Proportion of participants with successful treatment outcome, defined as clinical improvement (≥ 2 points on WHO R\&D BOSCI 1) by Day 28 post-randomisation.

  Day 28

Secondary Outcomes (15)

• Adverse Events of special interest

  Day 28

• Serious Adverse Events

  Day 28

• Survival

  Day 28

• Invasive mechanical ventilation

  Day 28

• Disease severity

  Day 28

Study Arms (2)

Arm 1

EXPERIMENTAL

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.

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

Arm 2

PLACEBO COMPARATOR

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

Biological: Standard of care (SOC) plus placebo

Interventions

COVID-19 convalescent plasma (CCP) plus standard of care (SOC) 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 1

Standard of care (SOC) plus placebo BIOLOGICAL

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

Arm 2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• South African National Blood Service: lead

Study Sites (2)

Universitas Hospital

Bloemfontein, Free State, 9301, South Africa

Location

Mitchells Plain Hospital

Cape Town, Western Cape, 7786, South Africa

Location

Related Publications (7)

• Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.

  PMID: 32123347 BACKGROUND

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 BACKGROUND

• Zu ZY, Jiang MD, Xu PP, Chen W, Ni QQ, Lu GM, Zhang LJ. Coronavirus Disease 2019 (COVID-19): A Perspective from China. Radiology. 2020 Aug;296(2):E15-E25. doi: 10.1148/radiol.2020200490. Epub 2020 Feb 21.

  PMID: 32083985 BACKGROUND

• Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3.

  PMID: 32052466 BACKGROUND

• 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.

  PMID: 32320003 BACKGROUND

• Thorlund K, Dron L, Park J, Hsu G, Forrest JI, Mills EJ. A real-time dashboard of clinical trials for COVID-19. Lancet Digit Health. 2020 Jun;2(6):e286-e287. doi: 10.1016/S2589-7500(20)30086-8. Epub 2020 Apr 24. No abstract available.

  PMID: 32363333 BACKGROUND

• Yuen KS, Ye ZW, Fung SY, Chan CP, Jin DY. SARS-CoV-2 and COVID-19: The most important research questions. Cell Biosci. 2020 Mar 16;10:40. doi: 10.1186/s13578-020-00404-4. eCollection 2020.

  PMID: 32190290 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sean Wasserman, A/Professor

  CIDRI-Africa, University of Cape Town

  STUDY CHAIR

• Karin vandenBerg, Dr

  South African National Blood Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Neither participants nor the investigators will be aware of the participant's treatment allocation until the end of the study (double blinding). Blinding will be maintained by local blood bank preparing the appropriate IP and Placebo. Unmasking procedures are detailed by SOP
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Site Principal Investigator

Model Details: Participant identification numbers (PIN), assigned at the screening/enrolment visit, will be used throughout the study. After signing the informed consent document, eligible participants will be randomised to one of the treatment arms, stratified by study site, age group (\<=65; \>65 years old) and body mass index (BMI) (\<30; \>=30 kg/m2). An electronic randomisation application will generate the treatment allocation. The trial Program Manager (PM), who will have no direct contact with trial participants or involvement in eligibility assessment or outcome assignment, will maintain the randomisation code.

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 18, 2020
• Study Start: September 21, 2020
• Primary Completion: December 30, 2021
• Study Completion: July 31, 2022
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Undecided
• Access Criteria: undecided

Locations

ZA (2)