COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46389

Dr Adarsh Shetty

medicalaffairs@guficbio.com

2020-09-23

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1.Male/females of â?¥ 18 years of age at the time of consent <br/ >2.Patient who can and willing to provide written Informed Consent <br/ >3 Moderate Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test /any other confirmatory tests <br/ >4 Patient with pneumonia with no signs of severe disease <br/ >5 If the patient presents any one of the following features: <br/ >-Respiratory rate of â?¥â??24 breath/min <br/ >-SpO2 (oxygen saturation) â?¤â??94% on room air <br/ >6.Patient/ patientâ??s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements <br/ >

Male/females of â?¥ 18 years of age at the time of consent <br/ >2 The patient who can and willing to provide written Informed Consent <br/ > Moderate Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection <br/ >confirmed by polymerase chain reaction (PCR) test /any other confirmatory tests <br/ >4. Patient with pneumonia with no signs of severe disease <br/ >5. If the patient presents any one of the following features: <br/ >- Respiratory rate â?¥ 24 breath/min to < 30 breath/min <br/ >- SpO2 (oxygen saturation) >90% to â?¤ 94% on room air <br/ >6. Patient/ patientâ??s LAR understands and is willing to participate in the clinical <br/ >study and can comply with clinical trial protocol requirements <br/ >The patient who has participated in another trial with an investigational drug within 1 <br/ >a month prior to this trial. <br/ >Patients who, in the judgment of the investigator will be unlikely to comply with <br/ >the requirements of this protocol

2

Dr Om Shrivastava

18

100

India

Moderate disease at enrollment

3: Moderate disease at enrollment

20

1.Duration of ICU stay [from baseline to End of study (Day 7)] <br/ >2.Ventilator duration [from baseline to End of study (Day 7)] <br/ >3.Incidences of all-cause hospital mortality [ Time Frame: From date of Drug <br/ >administered until the date of hospital discharge or date of death from any cause; <br/ >whichever came first; assessed up to 28 days] <br/ >4.Duration of hospitalization [ from baseline to hospital discharge]Timepoint: 1.Day 1 to Day 7 <br/ >2.Day 1 to Day 7 <br/ >3.Day 1 to Day 28 <br/ >4.Day 1 to Baseline

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

Not reported

[{"arm_notes": "", "treatment_id": 1290, "treatment_name": "Thymosin a-1", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]