Effect of AEV01 (Kutki) for Mild COVID19 Elderly patients

Phase 3

Completed

Conditions: Coronavirus as the cause of diseases classified elsewhere. Ayurveda Condition: Janapadoddhwansa,

Brief Summary: | |

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|The selected 70 Participants will be randomized into 2 groups with 35 in each group. Placebo Group patients diagnosed as mild SARS-CoV-2 infection will receive Placebo + standard of care treatment(as per hospital regulation) as per the WHO/ICMR guidelines and Test Group patients diagnosed as mild SARS-CoV-2 infection will receiveAEV01+ standard of care treatment (as per hospital regulation) as per the WHO/ICMR guidelines. The primary outcome measures will be to assess the efficacy of the drug as follows; **Time for clinical improvement** [Time Frame: up to Day 30], which is defined as; 1. Normalization of pyrexia and body pain 2. Respiratory rate less than 24/minute 3.Spo2 rate greater than 94% 4. Relief from cough and maintenance of above for more than 72 hours. The secondary outcome measure will be ; 1. Percentage of subjects reporting each severity rating on a 8-point ordinal scale. 2. Change from baseline in various lab parameters. The results of the Placebo and treatment arm will be analyzed and compared.

Recruitment & Eligibility

Inclusion Criteria

Willing and able to provide written informed consent prior to performing study procedures.
Adult patients aged more than 50 years with SARS-CoV-2 infection and mild disease.
Patients with Mild (uncomplicated) Illness is defined as â€“ a.Diagnosed with COVID-19 by a standardized RT-PCR assay AND b.Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND c.No signs of a more serious lower airway disease AND d.RR<20, HR <90, oxygen saturation (pulse oximetry) > 94% on room air.

Exclusion Criteria

Participants with moderate and severe illness of COVID19.
Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) 3.Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR< 30) 4.Immuno-compromised patients on medications.
5.Participation in any other clinical trial of an experimental treatment for COVID-19 6.
Consideration by the investigator, for any reason, that the participant is not an eligible candidate to receive study treatment.

Primary Outcome Measures

Name	Time	Method
Time for clinical improvement , which is defined as;	Day 1 to Day 30
1. Normalization of pyrexia and body pain	Day 1 to Day 30
2. Respiratory rate less than 24/minute	Day 1 to Day 30
3.Spo2 rate greater than 94%	Day 1 to Day 30
4. Relief from cough and maintenance of above for more than 72 hours.	Day 1 to Day 30

Secondary Outcome Measures

Name	Time	Method
1. Percentage of subjects reporting each severity rating on a 8-point ordinal scale.	2. Change from baseline in the following lab parameters namely, CBC, ESR, RBS, CRP, LFT, RFT, Serum electrolytes, serum ferritin, D-dimer, CD4, CD8, TNF-ï¡, IL-6, Covid-19 IgM & IgG and HRLCT scan.

Locations (3): PM Medical Centre
🇮🇳
Vellore, TAMIL NADU, India
Rajarajeswari Medical College and Hospital
🇮🇳
Mysore, KARNATAKA, India
Sri Sai Ram Ayurveda Medical college and Research centre
🇮🇳
Chennai, TAMIL NADU, India
PM Medical Centre
🇮🇳Vellore, TAMIL NADU, India
Dr Ramesh Kannan
Principal investigator
7708925866
srkguruvarshan@gmail.com