COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04535856

Dr. Muhammad Karyana, MPH

m.karyana@ina-respond.net

2020-09-02

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: age of 19 years or older at the time of screening those who have been confirmed covid-19 infection through pcr test patients with mild or moderate covid-19 who meet national ews (0~6) those who have given written consent and voluntarily decided to participate before the screening procedure after understanding the detailed description of the clinical trial. those who are suitable as subjects for this clinical study when judged by physical examination, clinical laboratory test, and other medical examination as stated in the flowchart of protocol.

those who have history of hypersensitivity to the components of the investigational product or the reference product those with viral or bacterial pneumonia other than expected indications patients receiving organ transplants within 6 months of screening patients with a history of pulmonary embolism patients who have indications of investigational products as an underlying disease (ex. hiv patients in the clinical study of antiretroviral drugs) patients who are pregnant or lactating those who are determined by the investigator to be unsuitable for participation in the clinical trial due to other reasons including the results of the clinical laboratory test. patients participating in other clinical studies

3

Ina-Respond

19

100

Indonesia

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

9

Incidence of TEAE* in Treatment group

None

Phase 1

[{"arm_notes": "", "treatment_id": 65, "treatment_name": "Allogeneic mesenchymal stem cell", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 65, "treatment_name": "Allogeneic mesenchymal stem cell", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]