COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62258

Adarsh Verma

mugdha.tapdiya@syneoshealth.com

2021-12-16

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1) Patients aged greater than or equal to 18 years <br/ > 2) Patients diagnosed with COVID-19 infection and pneumonia <br/ > 3) Patients who have voluntarily decided to participate in the study and signed the informed consent form If a patient cannot provide consent on his or her own, informed consent by a legally authorized representative may be obtained.

1) Patients with history of hypersensitivity to the study drug <br/ > 2) Female patients, either who are or may be pregnant or who are breastfeeding, or female patients of child-bearing potential who are unable to use adequate contraception during the study <br/ > 3) Patients who are deemed to ineligible to participate in the study for other reasons by the investigator

2

Chong Kun Dang Pharmaceutical Corp

18

99

Argentina;Brazil;India;Democratic People's Republic of Korea;Peru;Russia;Thailand;Ukraine

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

586

Time to recoveryTimepoint: Time Frame: From day1 to day 28. <br/ >Day of recovery is defined as the first day on which the subject meets the criteria

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 291, "treatment_name": "Ckd-314", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]