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Trial - ISRCTN49832318


Column Value
Trial registration number ISRCTN49832318
Full text link
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Contact
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

rbihariesingh@azp.sr

Registration date
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-09-02

Recruitment status
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

unclear

Study aim
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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.

Exclusion criteria
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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

Number of arms
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Academic Hospital Paramaribo

Inclusion age min
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

Countries
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Suriname

Type of patients
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Moderate disease at enrollment

Severity scale
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

3: Moderate disease at enrollment

Total sample size
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

210

primary outcome
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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.

Notes
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]