Effect of convalescent plasma in early course of COVID-19 disease

ISRCTN ISRCTN49832318
DOI https://doi.org/10.1186/ISRCTN49832318
Secondary identifying numbers IAG.2492-2021
Submission date
01/09/2021
Registration date
02/09/2021
Last edited
03/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
World knowledge about COVID-19 infection is accumulating and data about the clinical presentation of infected patients is ongoing. Common known treatments, including ribavirin and interferon, however, lack evidence. Although drugs with specific anti-coronavirus avidity have been identified, as yet only anti-inflammatory interventions for COVID-19 have been approved. Previous reports on other viral infections including SARS have suggested that convalescent plasma (CP) or serum is effective where no other treatment is available or in an emergency.
Convalescent plasma therapy uses blood from people who've recovered from an illness to help others recover.
Access to Convalescent Plasma therapy in a low-resource setting is enabled by the novel filtration device Hemoclear, which is easy to implement. Equitable access to such methods allows readiness in case of viral mutations or new pandemics.

Who can participate?
Patients (aged 18 years or above) with laboratory-confirmed COVID-19 who are admitted to the non-ICU ward with respiratory failure

What does the study involve?
Following informed consent, patients will be randomized into one of two groups: one group will receive 220 ml of convalescent plasma and the other group will receive a similar volume of NaCl 0.9%.

What are the possible benefits and risks of participating?
Benefits of this study may include shorter stay in hospital and a decrease in mortality. The risks of plasma infusion are comparable to risks associated with regular blood transfusions. These include transfusion reactions and transmission of (unknown) transmittable diseases. Maximal precautions will be taken against these risks.

Where is the study run from?
Academic Hospital Paramaribo (Suriname)

When is the study starting and how long is it expected to run for?
June 2021 to April 2022

Who is funding the study?
Academic Hospital Paramaribo (Suriname)

Who is the main contact?
Dr Rosita Bihariesingh-Sanchit, bihariesingh@hotmail.com

Contact information

Dr Rosita Bihariesingh-Sanchit
Scientific

Kwattaweg 639
Wanica
-
Suriname

ORCiD logoORCID ID 0000-0003-0646-9507
Phone +596 8753150
Email rbihariesingh@azp.sr

Study information

Study designOpen-label randomized prospective clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet 40356 PIS v1.2 22June2021.pdf
Scientific titleSURCOVID trial: A randomized controlled trial using convalescent plasma early during moderate COVID-19 disease course in Suriname
Study acronymSURCOVID
Study objectivesThe primary objective of this study is to examine the effect of early convalescent plasma administration in the COVID non-ICU ward on clinical outcome.
Ethics approval(s)Approved 29/07/2021, Suriname Ministry of Health's Ethics Review Board (Henck Arron straat 64, 0000 Paramaribo, Suriname; +597 474941; secdir.volksgezondheid@gov.sr), ref: IAG.2492-2021
Health condition(s) or problem(s) studiedCOVID-19 (SARS-CoV-2 infection)
InterventionAfter referral to the the non-ICU COVID-19 ward, the patients were treated with dexamethasone standard therapy. After being randomized by sealed envelope the patients receive convalescent plasma or placebo treatment added to the standard therapy.

An interim-analysis for efficacy and harm will be performed on the primary endpoint when 50% of patients have been included and have been followed up for at least 30 days, and follow-up will continue until discharge or death before day 60.
Intervention typeBiological/Vaccine
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)COVID-19 convalescent plasma
Primary outcome measureDevelopment of severe respiratory disease, defined as a respiratory rate of 30 breaths per minute or more, an oxygen saturation of less than 93% while the patient was breathing ambient air, or both, measured for up to 60 days from baseline.
Secondary outcome measuresMeasured using patient records:
1. Clinical status assessed by the ordinal scale on days 0, 3, 7, and 15 [Time Frame: up to 15 days]
2. The differences in oxygen intake methods [Time Frame: up to 15 days]
2.1. No need for supplemental oxygenation
2.2. Nasal catheter oxygen inhalation
2.3. Mask oxygen inhalation
2.4. Noninvasive ventilator oxygen supply
2.5. Invasive ventilator oxygen supply
3. Duration (days) of supplemental oxygenation [Time Frame: up to 15 days]
4. Duration (days) of mechanical ventilation [Time Frame: up to 15 days]
5. The mean PaO2/FiO2 [Time Frame: up to 15 days] if applicable
6. The detection frequency could be increased according to the clinician's decision
7. Time to COVID-19 negativity in respiratory tract specimens [every 3 days] [Time Frame: up to 15 days]
8. Dynamic changes of COVID-19 antibody titer in blood [Time Frame: up to 15 days]. The antibody titer is detected on days 0, 3, 7 and 15.
9. Dynamic changes of IL-6 levels in blood [Time Frame: up to 15 days]. The titer is detected on days 0, 3, 7 and 15
10. MCU/ICU admission
11. Length of MCU/ICU (days) [Time Frame: up to 28 days]
12. Length of hospital stay (days) [Time Frame: up to 28 days]
13. All cause mortality [Time Frame: up to 28 days]
Overall study start date01/06/2021
Completion date01/04/2022

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants210
Key inclusion criteria1. COVID-19 positive patients who have understood and signed the informed consent
2. Aged ≥18 years
3. Hospital admitted patients with moderate COVID-19 to the non-ICU ward: Laboratory confirmed infection with COVID-19.
Key exclusion criteria1. Severe or life threatening respiratory disease upon admission
2. Viral pneumonia with other viruses besides COVID-19
3. Ineligible for Convalescent Plasma Therapy
4. Participation in other studies.
5. Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial
6. Refusal of informed consent study participation by Donor and/or Patient
7. Known IgA deficiency
8. Medical conditions in which receipt of 220 ml volume may be detrimental to the patient (e.g.decompensated congestive heart failure)
9. Females who are pregnant or breast feeding
Date of first enrolment01/09/2021
Date of final enrolment01/02/2022

Locations

Countries of recruitment

  • Suriname

Study participating centres

Academic Hospital Paramaribo
Flustraat 1-3
Paramaribo
-
Suriname
Wanica Regional Hospital
Vredenburg Serie B #39
Lelydorp
-
Suriname

Sponsor information

Academic Hospital Paramaribo
Hospital/treatment centre

Flu Straat
Paramaribo
-
Suriname

Phone +597 443222
Email credan@azp.sr
Website http://www.azp.sr/
ROR logo "ROR" https://ror.org/01ky0w731

Funders

Funder type

Hospital/treatment centre

Academisch Ziekenhuis Paramaribo [Academic Hospital Paramaribo]

No information available

Results and Publications

Intention to publish date01/10/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planTrial results will always be submitted for publication in a peer reviewed scientific journal regardless of the outcome of the trial – unless the trial was terminated prematurely and did not yield sufficient data for publication.
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version 1.2 22/06/2021 02/09/2021 No Yes
Protocol file version 1.2 12/06/2021 02/09/2021 No No

Additional files

40356 Protocol v1.2 12June2021.pdf
40356 PIS v1.2 22June2021.pdf

Editorial Notes

03/09/2021: Internal review.
02/09/2021: Trial's existence confirmed by Suriname Ministry of Health's Ethics Review Board