A clinical study to see effect of ArtemiC in patients with COVID-19

Phase 2

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/07/026789
• Lead Sponsor: MGC Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-11-25
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Confirmed SARS-CoV-2 infection.

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.

3. Age: 18 years old and above.

4. Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).

5. Ability to receive treatment by spray into the oral cavity

Exclusion Criteria

1. Tube feeding or parenteral nutrition.

2. Oxygen requirements beyond use of nozzles or simple mask as per score 4

3. Respiratory decompensation requiring mechanical ventilation.

4. Uncontrolled diabetes type 2.

5. Autoimmune disease.

6. Pregnant or lactating women.

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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/ ><br>2.Percentage of participants with definite or probable drug related adverse eventsTimepoint: 15 Days

Secondary Outcome Measures

Name	Time	Method
1.Time until negative PCR <br/ ><br>2. Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms <br/ ><br>3.COVID-19 related survival <br/ ><br>4.Incidence and duration of mechanical ventilation <br/ ><br>5.Incidence of Intensive Care Init (ICU) stay <br/ ><br>6.Duration of ICU stay <br/ ><br>7.Duration of time on supplemental oxygen <br/ ><br>8.Additional Data will be recorded to complete the Core Set of OutcomesTimepoint: 15 Days