COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53090

Navid Reza Shahtaghi

subheetjain.pharma@gndu.ac.in

2021-03-08

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

a. Patients of either sex, 18 to 75 years of age (both inclusive). <br/ >b. Patients with diagnosis of coronavirus (SARS-CoV-2) infection conformed by polymerase chain reaction (PCR) test and sign of mild acute respiratory infection or with respiratory stress. <br/ >c. Patients with body muscle pain/fatigue. <br/ >d. Able to abide the dietary regime mentioned by the investigator. <br/ >e. Willing to come for regular follow â??up visits. <br/ >f. Able to give written informed consent. <br/ >

a. Known history of hypersensitivity to dietary supplements. <br/ >b. Volunteers receiving any COVID-19 specific antiviral treatment. <br/ >c. Concurrent respiratory diseases such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days) prior to COVID-19 diagnosis. <br/ >d. Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I. <br/ >e. Volunteers having systemic diseases like diabetes mellitus (Type I or Type II) and other debilitating metabolic diseases. <br/ >f. Pregnant or lactating women <br/ >g. Female subjects of childbearing potential not willing to use contraceptive methods <br/ >h. Male subjects not willing to use contraceptive methods <br/ >i. On-going treatment with herbals or any other immune boosting dietary supplements. <br/ >j. History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing. <br/ >k. Patients with ARDS of Cardiac origin <br/ >

2

Department of Pharmaceutical Sciences Guru Nanak Dev University Amritsar

18

75

India

Mild disease at enrollment

1: Mild disease at enrollment

60

a. Body Temperature. <br/ >b. pO2; pCO2 (blood gas analysis; daily until the patient is wean off the ventilator). <br/ >c. Showing improvement P/ F ratio <br/ >d. Subjectâ??s feedback on muscle fatigue and overall well-being; atleast 5 days from last visit (post COVID-19). <br/ >e. Chest X Ray or CT shows improved pulmonary edema or bilateral; patchy alveolar opacities/ consolidations â??â??white lungâ??â?? appearance. <br/ >Timepoint: 0; 3 and 5 day

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 704, "treatment_name": "Ketone ester", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]