COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47691

Mr Vairamuthu Ammaiyappan

medicalaffairs@guficbio.com

2020-10-07

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Male or female of more than or equal to 18 years of age at the time of consent <br/ >2. Patient who can and willing to provide written Informed Consent <br/ >3. Patient or patientâ??s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements <br/ > <br/ >Inclusion criteria for moderate COVID-19 patients <br/ > <br/ >4. Moderate Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test or any other confirmatory tests <br/ >5. Patient with pneumonia with no signs of severe disease <br/ >6. If the patient presents any one of the following features: <br/ >- Respiratory rate of more than or equal to â??24 breath per min <br/ >- SpO2 (oxygen saturation) more than 90 percent to less than or equal to 94 percentage on room air <br/ > <br/ >Inclusion criteria for severe COVID-19 patients <br/ > <br/ >7. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test or any other confirmatory tests <br/ >8. If the patient presents any one of the following features: <br/ >- respiratory distress with a respiratory rate of more than or equal toâ??30 breath per min <br/ >- SpO2 (oxygen saturation) less than or equal toâ??90 percentage on room air <br/ >- PaO2 (arterial blood oxygen partial pressure) or FiO2 (Fraction of Inspired Oxygen) less than or equal toâ??200 mmHg (1 mmHgâ??equal toâ??0.133 kPa) <br/ >- Patient presents respiratory failure and requires mechanical ventilation support <br/ > <br/ >

1. Patient who has participated in any other clinical trial of an experimental treatment for COVID-19 <br/ >2. Patients with the presence of any pre-existing illness that, in the opinion of the investigator, would place the patient at an unreasonably increased risk through participation in this study. <br/ >3. Patient who has participated in another trial with an investigational drug within 1 month prior to this trial. <br/ >4. Female patient who is breast-feeding, pregnant, or intends to become pregnant during the study <br/ >5. Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol <br/ >

2

Gufic Biosciences

18

99

India

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

120

1. Incidences of all-cause hospital mortality [Time Frame: From the date of Drug administered until the date of hospital discharge or date of death from any cause; whichever came first; assessed up to 28 days] <br/ >2.Evaluation of Clinical progression/deterioration based on an 8-point ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D) [time frame up to 7 days] on Day 1; Screening and End of treatment (Day 7) <br/ >Timepoint: 1.Day 1 to Day 28 <br/ >2.Day 1 to Day 7 <br/ >3.From baseline to hospital <br/ >discharge

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

Phase 3

[{"arm_notes": "", "treatment_id": 1290, "treatment_name": "Thymosin a-1", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]