COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04567173

Deonne Thaddeus Gauiran

Not reported

2020-09-28

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - patient must be 19 years of age or older - hospitalized with covid-19 and confirmed via sars-cov-2 rt-pcr testing - patient is willing and able to provide written consent and comply with all protocol requirements - patient agrees to storage of specimens for future testing

female subjects with positive pregnancy test, are breastfeeding or planning to become pregnant/breastfeed during the study period symptomatic illness exceeding 14 days from onset of illness at time of enrollment icu admission on initial presentation at the hospital (includes patients with clinical indications for icu admission as follows: respiratory distress with requirement of o2 >6 lpm to maintain o2 sat >92% rapid escalation of o2 requirement/significant work of breathing hemodynamic instability: sbp <90, map <65 receipt of any blood products including pooled immunoglobulin or intravenous immunoglobulin (ivig) in the past 30 days prior to enrolment known iga deficiency presence of any contraindication to transfusion (or history of prior severe reactions to transfusion of blood products)

2

University of the Philippines

19

100

Philippines

Moderate disease at enrollment

3: Moderate disease at enrollment

44

Incidence of serious adverse events

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]