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

Phase 2

Completed

• Conditions: Coronavirus as the cause of diseases classified elsewhere. Ayurveda Condition: Janapadodhwamsa Vikara ,

• Registration Number: CTRI/2021/02/031520
• Lead Sponsor: MGC Pharmaceuticals Ltd

Brief Summary

A Phase II, Open label controlled clinical study designed to evaluate the effect of ArtemiC in patients diagnosed with COVID-19.

**The primary outcomes of the study are**



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****of the study****are**

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 Unit (ICU) stay

Duration of ICU stay

Duration of time on supplemental oxygen

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-25
• Study Completion: 2021-03-06
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Confirmed SARS-CoV-2 infection.
• 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 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.

Exclusion Criteria

• Tube feeding or parenteral nutrition.
• 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.
• Uncontrolled diabetes type 2.
• Autoimmune disease.
• Pregnant or lactating women.
• 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 ≤ 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

Trial Locations

Locations (1)

Govt. Medical College & Govt. General Hospital (Old RIMSGGH); 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Govt. Medical College & Govt. General Hospital (Old RIMSGGH)

🇮🇳Srikakulam, ANDHRA PRADESH, India

Dr K Sunil Naik

Principal investigator

91-9440828299

drsunilnaikggh@gmail.com