Effect of convalescent plasma in early course of COVID-19 disease
ISRCTN | ISRCTN49832318 |
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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
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
Scientific
Kwattaweg 639
Wanica
-
Suriname
0000-0003-0646-9507 | |
Phone | +596 8753150 |
rbihariesingh@azp.sr |
Study information
Study design | Open-label randomized prospective clinical trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | 40356 PIS v1.2 22June2021.pdf |
Scientific title | SURCOVID trial: A randomized controlled trial using convalescent plasma early during moderate COVID-19 disease course in Suriname |
Study acronym | SURCOVID |
Study objectives | The 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) studied | COVID-19 (SARS-CoV-2 infection) |
Intervention | After 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 type | Biological/Vaccine |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | COVID-19 convalescent plasma |
Primary outcome measure | Development 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 measures | Measured 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 date | 01/06/2021 |
Completion date | 01/04/2022 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 210 |
Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/09/2021 |
Date of final enrolment | 01/02/2022 |
Locations
Countries of recruitment
- Suriname
Study participating centres
Paramaribo
-
Suriname
Lelydorp
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Suriname
Sponsor information
Hospital/treatment centre
Flu Straat
Paramaribo
-
Suriname
Phone | +597 443222 |
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credan@azp.sr | |
Website | http://www.azp.sr/ |
https://ror.org/01ky0w731 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
Intention to publish date | 01/10/2022 |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Data sharing statement to be made available at a later date |
Publication and dissemination plan | Trial 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 plan | The 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? |
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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
Editorial Notes
03/09/2021: Internal review.
02/09/2021: Trial's existence confirmed by Suriname Ministry of Health's Ethics Review Board