A study to assess the safety and effectiveness of Thymosin �±-1 (T�±1) used for the treatment of Moderate to severe COVID 19 Patients.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/10/028277
- Lead Sponsor
- Gufic Biosciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 105
1.Male or female of more than or equal to 18 years of age at the time of consent
2.Patient who can and willing to provide written Informed Consent
3.Patient or patientââ?¬•s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements
Inclusion criteria for moderate COVID-19 patients
4.Moderate Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test or any other confirmatory tests
5.Patient with pneumonia with no signs of severe disease
6.If the patient presents any one of the following features:
-Respiratory rate of more than or equal to �24 breath per min
-SpO2 (oxygen saturation) more than 90 percent to less than or equal to 94 percentage on room air
Inclusion criteria for severe COVID-19 patients
7.Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test or any other confirmatory tests
8.If the patient presents any one of the following features:
-respiratory distress with a respiratory rate of more than or equal to�30 breath per min
-SpO2 (oxygen saturation) less than or equal to�90 percentage on room air
-PaO2 (arterial blood oxygen partial pressure) or FiO2 (Fraction of Inspired Oxygen) less than or equal to�200 mmHg (1 mmHg�equal to�0.133 kPa)
-Patient presents respiratory failure and requires mechanical ventilation support
1.Patient who has participated in any other clinical trial of an experimental treatment for COVID-19
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.
3.Patient who has participated in another trial with an investigational drug within 1 month prior to this trial.
4.Female patient who is breast-feeding, pregnant, or intends to become pregnant during the study
5.Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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/ ><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/ ><br>Timepoint: 1.Day 1 to Day 28 <br/ ><br>2.Day 1 to Day 7 <br/ ><br>3.From baseline to hospital <br/ ><br>discharge
- Secondary Outcome Measures
Name Time Method 1.Duration of ICU stay <br/ ><br>2. Ventilator duration <br/ ><br> Duration of hospitalization <br/ ><br>3.Change in Total lymphocytes count, CD4, and CD8 count <br/ ><br>4.Change in Ferritin levels, IL-6, LDH, CRP, D-dimer <br/ ><br>5.Change in SpO2 level <br/ ><br>6.Number of Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (TESAE). <br/ ><br> <br/ ><br>Timepoint: 1.Baseline to Day 7 <br/ ><br>2. Baseline to Day 7 <br/ ><br>3. Baseline to Day 7 <br/ ><br>4. Screening Day 1 to Day 7 <br/ ><br>5. Day 1 to End of Study