COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCTs031200374

Hidetoshi Nomoto

covipla-rct@hosp.ncgm.go.jp

2021-02-24

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

(1) Patients who have given written consent to participate in the study from themselves or their guardians.(2) Hospitalized patients with a confirmed diagnosis of COVID-19 by PCR or LAMP, antigen testing, or other methods.(3) Patients who meet all of the following requirements at the time of admission.1)Within 5 days of onset2) SpO2 of 95% or higher in room air3) Aged 40 years or older or have one of the following underlying diseasesRenal dysfunction, chronic obstructive pulmonary disease (COPD), cardiac disease, cerebrovascular disease, malignancy, obesity, diabetes, hypertension, immunosuppressed state.(4) 20 years of age or older at the time of obtaining consent.(5) A person who is infected for the first time

(1)Those who are pregnant or breastfeeding(2)Those whose religious beliefs do not support the administration of blood transfusions.(3)Those who are participating in an interventional study that provides therapeutic intervention for COVID-19.(4)Those who have been vaccinated against SARS-CoV-2.(5)Patients who have already received convalescent plasma.(6)Those with a history of allergy to blood products.(7)Patients with plasma protein deficiency such as IgA(8)Patients with NYHA class III or IV heart failure(9)Others who are judged inappropriate for inclusion in the study by the principal investigator, principal investigator, or sub-investigator.

2

Sho Saito

20

100

Japan

Moderate disease at enrollment

3: Moderate disease at enrollment

200

Time-weighted mean change in the amount of SARS-CoV-2 virus in nasopharyngeal swabs from day 0 to day 3 and day 5 of treatment

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"}]