Effect of AEV01 (Kutki) for Mild COVID19 Elderly patients

Phase 3

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2021/04/032804
• Lead Sponsor: PM Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-08-27
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

1. Willing and able to provide written informed consent prior to performing study procedures.

2. 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

1. Participants with moderate and severe illness of COVID19.

2. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time for clinical improvement , which is defined as; <br/ ><br>1. Normalization of pyrexia and body pain <br/ ><br>2. Respiratory rate less than 24/minute <br/ ><br>3.Spo2 rate greater than 94% <br/ ><br>4. Relief from cough and maintenance of above for more than 72 hours. <br/ ><br>Timepoint: 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. <br/ ><br>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. <br/ ><br>3.Change from baseline in National Early Warning Score <br/ ><br>4.Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs) / SAEs <br/ ><br>5.Time to Recovery <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Day 1 to Day 30