Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: ArtemiC medical spray with standard of care treatment: ArtemiC is a medical nasal spray combined of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (15 mg/ml) and vitamin C (60
Sponsors
MGC Pharmaceuticals Ltd
Biosphere Clinical Research PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: 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 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 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 2.Percentage of participants with definite or probable drug related adverse eventsTimepoint: 15 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Time until negative PCR 2.Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms 3.COVID-19 related survival 4.Incidence and duration of mechanical ventilation 5.Incidence of Intensive Care Unit (ICU) stay 6.Duration of ICU stay 7.Duration of time on supplemental oxygen 8.Additional Data will be recorded to complete the Core Set of OutcomesTimepoint: 15 Days | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Oz Innovative Solutions Pty Ltd
Outcome results
None listed