COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45111

Dr Neeta Nargundkar

drneeta@biospherecro.com

2020-07-25

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1. Confirmed SARS-CoV-2 infection. <br/ >2. Hospitalized patient with COVID-19 of moderate stable or worsening severity not requiring ICU admission, and on the other hand not experiencing clinical improvement under ongoing standard care. <br/ >3. Age: 18 years old and above. <br/ >4. Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient). <br/ >5. Ability to receive treatment by spray into the oral cavity

1. Tube feeding or parenteral nutrition. <br/ >2. Oxygen requirements beyond use of nozzles or simple mask as per score 4 <br/ >3. Respiratory decompensation requiring mechanical ventilation. <br/ >4. Uncontrolled diabetes type 2. <br/ >5. Autoimmune disease. <br/ >6. Pregnant or lactating women. <br/ >7. Need for admission to ICU in the course of the present hospitalization at any time prior to completion of the recruitment to the study. <br/ >8. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.

2

MGC Pharmaceuticals Ltd

18

65

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

50

1.Time to clinical improvement; defined as a national Early Warning Score 2 (NEWS2) of â?¤ 2 Maintained for 24 Hours in comparison to routine treatment <br/ >2.Percentage of participants with definite or probable drug related adverse eventsTimepoint: 15 Days

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

Phase 2

[{"arm_notes": "", "treatment_id": 119, "treatment_name": "Artemisinin", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]