Investigator Initiated Study to Evaluate the Effectiveness and Safety of Thymosin α-1 (Tα1) in Moderate COVID-19 Patients

Not yet recruiting

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

• Registration Number: CTRI/2020/09/027992
• Lead Sponsor: Dr Om Shrivastava

Brief Summary

This is a Single Centre, Two Arm (Standard control) Randomized  Investigator-Initiated Study.

 Thymosin-?1 (T?1), 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), in moderate 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 Treatment arm A or B in 1:1 ratio patients will be administered 2 subcutaneous injections of 1.6 mgThymosin-?1 (T?1)  twice daily along with SOC for 7 days as per the guidelines by the Government of India Ministry of Health & Family Welfare. During the study Demography, physical examination including vital signs (B.P, 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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-09-16
• Study Start: 2020-09-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Male/females of ≥ 18 years of age at the time of consent 2 The patient who can and willing to provide written Informed Consent Moderate Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test /any other confirmatory tests 4. Patient with pneumonia with no signs of severe disease 5. If the patient presents any one of the following features:.
• Respiratory rate ≥ 24 breath/min to < 30 breath/min.
• SpO2 (oxygen saturation) >90% to ≤ 94% on room air 6. Patient/ patient’s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements The patient who has participated in another trial with an investigational drug within 1 a month prior to this trial. 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.Duration of ICU stay [from baseline to End of study (Day 7)]	1.Day 1 to Day 7 | 2.Day 1 to Day 7 | 3.Day 1 to Day 28 | 4.Day 1 to Baseline
2.Ventilator duration [from baseline to End of study (Day 7)]	1.Day 1 to Day 7 | 2.Day 1 to Day 7 | 3.Day 1 to Day 28 | 4.Day 1 to Baseline
3.Incidences of all-cause hospital mortality [ Time Frame: From date of Drug	1.Day 1 to Day 7 | 2.Day 1 to Day 7 | 3.Day 1 to Day 28 | 4.Day 1 to Baseline
administered until the date of hospital discharge or date of death from any cause,	1.Day 1 to Day 7 | 2.Day 1 to Day 7 | 3.Day 1 to Day 28 | 4.Day 1 to Baseline
whichever came first, assessed up to 28 days]	1.Day 1 to Day 7 | 2.Day 1 to Day 7 | 3.Day 1 to Day 28 | 4.Day 1 to Baseline
4.Duration of hospitalization [ from baseline to hospital discharge]	1.Day 1 to Day 7 | 2.Day 1 to Day 7 | 3.Day 1 to Day 28 | 4.Day 1 to Baseline

Secondary Outcome Measures

Name	Time	Method
Change in Total lymphocytes count CD4 and CD8 count from baseline	Change in Ferritin levels IL-6 LDH,CRP D-dimer from baseline

Trial Locations

Locations (1)

Kasturba Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Kasturba Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Om Shrivastava

Principal investigator

919869118780

omshrivastav70@gmail.com