COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=63848

Dr Sandeep Singh

sandeep.singh@cbccusa.com

2021-12-22

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

Patients must meet all inclusion criteria to be eligible for study Participation. <br/ > <br/ > 1. Willing and able to provide written informed consent, or with alegal representative who can provide informed consent, or <br/ > enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator prior to performing study procedures <br/ > 2. Male or female patients aged between 45 to 60 years, both <br/ > inclusive, with gender balance ensured through stratification upon randomization. <br/ > 3. Patient has COVID-19 symptoms less than or equal to 10 days with moderate <br/ > severity including any of the following consistent with classification of moderate disease severity: <br/ > O2 saturation (SpO2) 90 percent to less than or equal to93 percent on room air or <br/ > Respiratory rate greater than or equal to 24 per min, breathlessness <br/ > 4. Patients with score of 5 on WHO ordinal scale for clinical <br/ > improvement [non-invasive ventilation or high-flow oxygen] <br/ > Note: Patients admitted with immediate need for mechanical <br/ > ventilation are of a severity too critical for inclusion into this <br/ > protocol. Patients who are already in the hospital and have been removed from mechanical ventilation are not eligible. <br/ > 5. Vaccination status for COVID-19 will not influence eligibility for the study. <br/ > 6. Patient laboratory-confirmed COVID-19 infection as determined by PCR or other commercial or public health assay in any specimen, as documented by either of the following: <br/ > Patient has a SARS-CoV-2 PCR positive sample collected less than 72 hours prior to randomization <br/ > Patient has a SARS-CoV-2 PCR positive sample collected greater than or equal to72 hours prior to randomization, with a documented inability to obtain a repeat sample (e.g., due to lack of testing supplies, limited testing capacity, results taking greater than24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 pneumonia. <br/ > 7. Patient understands and agrees to comply with planned study procedures. <br/ > 8. Patient agrees to be placed on a prophylactic dose of <br/ > anticoagulation medication for prevention of deep venous <br/ > thrombosis (DVT) while hospitalized <br/ > 9. Patients who are women of childbearing potential must have a negative pregnancy test <br/ > <br/ >

Patients will not be eligible for study participation if they meet any of the exclusion criteria. <br/ > <br/ > 1. Patient has severe COVID-19 infection as per ICMR guideline <br/ > (Respiratory rate >30/min, breathlessness or SpO2 < 90% on <br/ > room air). Patients with WHO ordinal scale for clinical <br/ > improvement severity scores 6 or 7 at baseline will be excluded. <br/ > 2. Patient is currently receiving extracorporeal membrane <br/ > oxygenation (ECMO), nitric oxide therapy, or high-frequency <br/ > oscillatory ventilation <br/ > 3. Patient is unlikely to survive for > 24 hours from randomization, in the opinion of the investigator <br/ > 4. Patient has a history of chronic oxygen use or any pre-existing respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization <br/ > 5. Patient has a history of venous thromboembolism (VTE), DVT, or pulmonary embolus <br/ > 6. Patient has a malignancy of any type <br/ > 7. Patient has breast cancer or a history of breast cancer and now cancer free for < 5 years <br/ > 8. Patient has suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19) <br/ > 9. Patients with any of following laboratory results out of the ranges detailed below at screening should be discussed depending on their medication: <br/ > Absolute neutrophil count less than or equal to 1.0 Ã? 109/L <br/ > Platelets < 50 Ã? 109/L <br/ > Alanine aminotransferase or aspartate aminotransferase > 5 Ã? upper limit of normal <br/ > 10. Patient is sharing a ventilator, or co-ventilating, with any other patient. <br/ > 11. Patient has had treatment with immunomodulators or <br/ > immunosuppressant drugs, including but not limited to antiinterleukin (IL)-6, IL-6R, IL-1RA, IL-1 Beta within 7 days prior to randomization <br/ > 12. Patient has history of long-term use of antirejection or <br/ > immunomodulatory drugs <br/ > 13. Patient is pregnant or lactating <br/ > 14. Patient has severe chronic kidney disease greater than or equal to Stage 4 or requiring dialysis <br/ > 15. Patient has a known hypersensitivity to progesterone or DEX <br/ > 16. Patient is taking systemic corticosteroids for an indication other than COVID-19 <br/ > 17. Patient has known or active human immunodeficiency virus <br/ > (HIV)/ acquired immune deficiency syndrome (AIDS) infection <br/ > 18. Patient has known or active tuberculosis (TB) infection or evidence of latent TB <br/ > 19. Patient has known or active hepatitis B or hepatitis C <br/ > 20. History or presence of conditions that may place the patient at increased risk as determined by the investigator. <br/ > 21. Has taken other investigational drugs or participated in any <br/ > clinical study within 30 days or 5 half-lives (if known) of the <br/ > investigational drugâ??s PK, PD, or biological activity (if known), <br/ > whichever is longer, prior to first dose of study drug in this study or is currently participating in another clinical study. <br/ >

2

Evergreen Therapeutics Inc

45

60

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

44

Efficacy Endpoint: Proportion of patients showing 2 points improvement as per <br/ >WHO ordinal scale and mortality after 14 days of treatment. <br/ >Safety Endpoints: <br/ >Incidence of new bacterial; fungal; or opportunistic infection <br/ >Incidence of Grade 4 neutropenia (absolute neutrophil count [ANC] less than 500 per mm3) <br/ >Incidence of Grade 3-4 adverse events ([AEs]; clinical orlaboratory) <br/ >Incidence of serious adverse events (SAEs) <br/ >Incidence of abnormal electrocardiograms (ECGs) requiring clinical action <br/ >Proportion of patients with shock defined by persistent hypotension (systolic blood pressure (SBP) less than 90 mmHg or diastolic blood pressure (DBP) less than 60 mmHg) despite volume resuscitation; requiring vasopressors to maintain MAP greater than or equal to 65 mmHg and serum lactate level greater than 2mmol per L. <br/ >Timepoint: PD Blood Collection on Day 01; 04; 08; 15; 29; 58.

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

Phase 2

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