COVID-19 (SARS-CoV-2 infection) Infections and Infestations COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
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 pl
Sponsors
Academic Hospital Paramaribo
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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] | — |
Countries
Suriname
Outcome results
None listed