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

Phase 2

Completed

Brief Summary: This Study is A Phase II, controlled clinical study designed to evaluate the effect of ArtemiC in patients diagnosed with COVID-19.

The primary outcomes:

Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of

Percentage of participants with definite or probable drug related adverse events

The secondary outcomes:

Time until negative PCR

Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms

COVID-19 related survival

Incidence and duration of mechanical ventilation

Incidence of Intensive Care Init (ICU) stay

Duration of ICU stay

Duration of time on supplemental oxygen

Additional Data will be recorded to complete the Core Set of Outcomes

Recruitment & Eligibility

Inclusion Criteria

Confirmed SARS-CoV-2 infection.
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.
Age: 18 years old and above.
Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).
Ability to receive treatment by spray into the oral cavity.

Exclusion Criteria

Tube feeding or parenteral nutrition.
Oxygen requirements beyond use of nozzles or simple mask as per score 4 3.
Respiratory decompensation requiring mechanical ventilation.
Uncontrolled diabetes type 2.
Autoimmune disease.
Pregnant or lactating women.
Need for admission to ICU in the course of the present hospitalization at any time prior to completion of the recruitment to the study.
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.

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	15 Days
2.Percentage of participants with definite or probable drug related adverse events	15 Days

Secondary Outcome Measures

Name	Time	Method
1.Time until negative PCR	2. Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms

Locations (1): Mahatma Gandhi Missions Medical College & Hospital
🇮🇳
Aurangabad, MAHARASHTRA, India
Mahatma Gandhi Missions Medical College & Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
DrSyed Umar Quadri
Principal investigator
9923798702
umarazmed@gmail.com