A study to assess the safety and effectiveness of Thymosin α-1 (Tα1) used for the treatment of Moderate to severe COVID 19 Patients.

Phase 3

Completed

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/10/028277
• Lead Sponsor: Gufic Biosciences

Brief Summary

This is a Double-Blind, Multi-Center, Two- Arm, Randomized, Placebo-Controlled, Phase III Clinical Study

Thymosin- alpha1(Talpha1), a kind of polypeptide hormone produced by thymic epithelial cells can effectively increase T cell numbers, support T cell differentiation, maturation and reduce cell apoptosis.T?1 looks a potential treatment that can be dosed in combination with standard of care in patients with COVID 19. Hence in this present study, we plan to evaluate and compare the effectiveness and safety of T?1 in Combination with Standard of Care (SOC) and SOC alone, in moderate to severe COVID-19 patients. If found to be successful, will provide evidence to undertake a large-scale trial to cure COVID-19 infected patients. It will be a breakthrough invention in the medical field. Thus, the research poses potentially great benefits to society.



All subject eligible subjects will be getting medications as per the randomization schedule either Active arm or Placebo Arm in 2:1 ratio patients **with Moderate symptoms of COVID-19** will be administered 2 subcutaneous injections of Active Treatment (Containing 1.6mg Tα1) or Placebo along with SOC in the morning and 2 subcutaneous injections of Active Treatment (Containing 1.6mg Tα1) or Placebo in the evening along with SOC as per the randomization schedule, from Day 1 to Day 7 and **Patients with Severe symptoms of COVID-19** will be administered 2 Subcutaneous injections of Active Treatment (Containing 1.6mg Tα1) or Placebo  thrice daily

( each) in the morning, afternoon, and evening along with SOC as per the randomization schedule, from Day 1 to Day 7.

Standard of Care (SOC) will be given in both arms as per the revised guidelines of the Government of India Ministry of Health & Family Welfare. During the study Demography, Physical examination including vital signs (BP pulse rate, respiration rate, oxygen (O2) saturation, chest X-ray will be recorded. All patients will undergo clinical laboratory tests for biomarkers and for safety.

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Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-10
• Study Completion: 2021-10-14
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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 patient’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.

Exclusion Criteria

• 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]	1.Day 1 to Day 28 | 2.Day 1 to Day 7 | 3.From baseline to hospital | discharge
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)	1.Day 1 to Day 28 | 2.Day 1 to Day 7 | 3.From baseline to hospital | discharge

Secondary Outcome Measures

Name	Time	Method
1.Duration of ICU stay	2. Ventilator duration

Trial Locations

Locations (8)

Batra Hospital and Medical Research Centre; 🇮🇳 Delhi, DELHI, India

Dhiraj Hospital; 🇮🇳 Vadodara, GUJARAT, India

Grant Medical Foundation Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

King Georges Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Lifepoint Multispecialty Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Mantri Hospital; 🇮🇳 Pune, MAHARASHTRA, India

PGIMS, Rohtak; 🇮🇳 Rohtak, HARYANA, India

St Georges Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Batra Hospital and Medical Research Centre

🇮🇳Delhi, DELHI, India

Dr Dev Nath Jha

Principal investigator

911129957661

drdnjha@yahoo.co.in