Clinical study to evaluate the safety and efficacy of ATRICOV 452 for the treatment of COVID-19 along with the standard of care.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2021/01/030795
• Date of registration: 28-01-2021
• Prospective Registration: Yes
• Primary sponsor: Atrimed Pharmaceutical Pvt Ltd
• Public title: Clinical study to evaluate the safety and efficacy of ATRICOV 452 for the treatment of COVID-19 along with the standard of care.
• Scientific title: A Single blind, randomized, placebo-controlled, exploratory clinical study to evaluate the safety and efficacy of ATRICOV 452 for the treatment of COVID-19 along with the standard of care.
• Date of first enrolment: 01-02-2021
• Target sample size: 100
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51391
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Investigator Blinded
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Dr Harish S
• Affiliation: ICBio Clinical Research Pvt. Ltd.

• Name: Dr Harish S
• Affiliation: ICBio Clinical Research Pvt. Ltd.

Key inclusion & exclusion criteria

Inclusion criteria: 1.Both male and female adult populations aged from 18 to 60 years will be included in the study.

2.Confirmed RT-PCR positive for SARS CoV-2 and IgG â??ve symptomatic patients as determined by the principal investigator/ Physician.

3.Controlled Diabetes (Type 2 DM (Hb1Ac < 7) and Hypertension (Systolic BP <140 mm Hg or diastolic BP <90 mm Hg).

4.Patient with BMI from >=18 to <= 30 are included.

5.Patient is willing and able to comply with all trial requirements.

All the patients obtained written informed

consent form in English as well as native

language, according to national regulations.


Exclusion criteria: 1.If the physician finds vulnerability based on the history, nutritional status, physical appearance, or any other reason.

2.Judgment of the physician on likely need of ICU admission.

3.Known hepatic & kidney disease.

4.Known hypersensitivity to usual standard of care drug.

5.Known patient of cardiovascular disease, including congenital and ischemic heart disease, congestive cardiac failure.

6.Uncontrolled Type 2 DM (Hb1Ac >7), Insulin dependent DM & Uncontrolled HTN (systolic BP>=140 mm Hg or diastolic BP>=90 mm Hg.

7.Patients with BMI <18 and > 30 (Obese) are not included in the study.

8.Hemoglobin < 8 gm/dl are excluded.

9.Known patient of HIV or on any other anti-viral medication for a disease other than Covid-19.

10.Pregnant and lactating women.

11.Presence of debilitating diseases like Tuberculosis, Rheumatoid arthritis, Carcinoma, Known case of inflammatory autoimmune diseases of any kind, neurodemyelinating diseases like Multiple sclerosis, Transverse myelitis, Thyroid, adrenal, pituitary endocrine disorders, Renal failure, Inflammatory bowel disease.

12.Patients who had participated in another clinical trial with in the previous 30 days.

13.Patients under immune suppressants and steroid (steroid for any other disease than Covid-19).

14.Signs and symptoms, haematological, imaging investigations show signs of severe COVID will be excluded.

15.Any other medical conditions that is considered as unsuitable for the study by investigator.

16.Patient is not willing to give inform consent form.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Intervention1: ATRICOV 452: ATRICOV 452 (500mg) 2 capsules TID for 14 days + standard of care
Control Intervention1: Placebo of ATRICOV 452: Placebo of ATRICOV 452 (500mg) 2 capsules TID for 14 days + standard of care

Primary Outcome(s)

1.Time taken for clinical resolution of signs and symptom

2.Time taken for the conversion of COVID +ve to COVID -ve of throat swabs

3. Change in Disease progress markersTimepoint: From screening to 14 days

Secondary Outcome(s)

1.Frequency of requirement for supplemental oxygen or non-invasive ventilation.

2.Frequency of requirement for mechanical ventilation.

3.Decrement of symptoms like headache, myalgia, rhinorrhea, loss of taste, loss of smell, diarrhoea, fatigue.

4.Number of people who needed ICU admission & number of days in ICU

5.Number of days in the hospital stay

Timepoint: From screening to 14 days

Secondary ID(s)

ICBio/CR/APPL/1311/117 Version 01 dated 13 Nov 2020

Source(s) of Monetary Support

Atrimed Pharmaceutical Pvt. Ltd. No. 29-30, Prestige Meridian, 14th floor, Tower 2, MG Road, Bengaluru-560001 Karnataka, India

Ethics review

Status: Approved
Approval date: 13/01/2021
Contact:

Vedant Hospital Ethics Committee Research Department

Status: Approved
Approval date: 13/03/2021
Contact:

Lifepoint Research-Ethics committee

Results

• Date Completed: 16/06/2021