A clinical study to see the effect of ArtemiC in patients with COVID-19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/02/031520
- Lead Sponsor
- MGC Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. Confirmed SARS-CoV-2 infection.
2. Age: 18 years old and above.
3. Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).
4. Ability to receive treatment by spray into the nasal cavity
Cohort 1:
1.10 Patients clinically assigned as moderate [Presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 < 92% range 90-92% on room air, Respiratory Rate more or equal to 24 per minute]
2.Patients with a score of 4 (oxygen by mask or nasal prongs) on the 8- point ordinal scale of clinical status used by WHO at baseline assessment
Cohort 2:
1.10 patients clinically assigned as severe (Clinical signs of Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 < 90% on room air) but not critically ill (acute respiratory distress syndrome [ARDS], multi organ failure or septic shock).
2.Patients with a score of 5 (Non-invasive ventilation or high flow oxygen) on the 8- point ordinal scale of clinical status used by WHO at baseline assessment.
1. Tube feeding or parenteral nutrition.
2. Critically ill patients, defined as those who are candidates for endotracheal intubation and invasive mechanical ventilation and those with ARDS, septic shock or multi-organ failure at baseline.
3. Uncontrolled diabetes type 2.
4. Autoimmune disease.
5. Pregnant or lactating women.
6. 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 Unit (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