Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: EG009A Manufactured by: Frontage Laboratories, Inc. USA: Dose: 500 mg/2 mL,
Frequency: Loading doses (Days 1-3) 500 mg/2mL BID & Maintenance doses (days 8, 12, 15, 19, 22, 26) EG009A 50
Sponsors
Evergreen Therapeutics Inc
Eligibility
Inclusion criteria
Inclusion criteria: Patients must meet all inclusion criteria to be eligible for study Participation. 1. Willing and able to provide written informed consent, or with alegal representative who can provide informed consent, or 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 2. Male or female patients aged between 45 to 60 years, both inclusive, with gender balance ensured through stratification upon randomization. 3. Patient has COVID-19 symptoms less than or equal to 10 days with moderate severity including any of the following consistent with classification of moderate disease severity: O2 saturation (SpO2) 90 percent to less than or equal to93 percent on room air or Respiratory rate greater than or equal to 24 per min, breathlessness 4. Patients with score of 5 on WHO ordinal scale for clinical improvement [non-invasive ventilation or high-flow oxygen] Note: Patients admitted with immediate need for mechanical ventilation are of a severity too critical for inclusion into this protocol. Patients who are already in the hospital and have been removed from mechanical ventilation are not eligible. 5. Vaccination status for COVID-19 will not influence eligibility for the study. 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: Patient has a SARS-CoV-2 PCR positive sample collected less than 72 hours prior to randomization 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. 7. Patient understands and agrees to comply with planned study procedures. 8. Patient agrees to be placed on a prophylactic dose of anticoagulation medication for prevention of deep venous thrombosis (DVT) while hospitalized 9. Patients who are women of childbearing potential must have a negative pregnancy test
Exclusion criteria
Exclusion criteria: Patients will not be eligible for study participation if they meet any of the exclusion criteria. 1. Patient has severe COVID-19 infection as per ICMR guideline (Respiratory rate >30/min, breathlessness or SpO2 room air). Patients with WHO ordinal scale for clinical improvement severity scores 6 or 7 at baseline will be excluded. 2. Patient is currently receiving extracorporeal membrane oxygenation (ECMO), nitric oxide therapy, or high-frequency oscillatory ventilation 3. Patient is unlikely to survive for > 24 hours from randomization, in the opinion of the investigator 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 5. Patient has a history of venous thromboembolism (VTE), DVT, or pulmonary embolus 6. Patient has a malignancy of any type 7. Patient has breast cancer or a history of breast cancer and now cancer free for 8. Patient has suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19) 9. Patients with any of following laboratory results out of the ranges detailed below at screening should be discussed depending on their medication: Absolute neutrophil count less than or equal to 1.0 Ã?â?? 109/L Platelets Alanine aminotransferase or aspartate aminotransferase > 5 Ã?â?? upper limit of normal 10. Patient is sharing a ventilator, or co-ventilating, with any other patient. 11. Patient has had treatment with immunomodulators or immunosuppressant drugs, including but not limited to antiinterleukin (IL)-6, IL-6R, IL-1RA, IL-1 Beta within 7 days prior to randomization 12. Patient has history of long-term use of antirejection or immunomodulatory drugs 13. Patient is pregnant or lactating 14. Patient has severe chronic kidney disease greater than or equal to Stage 4 or requiring dialysis 15. Patient has a known hypersensitivity to progesterone or DEX 16. Patient is taking systemic corticosteroids for an indication other than COVID-19 17. Patient has known or active human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome (AIDS) infection 18. Patient has known or active tuberculosis (TB) infection or evidence of latent TB 19. Patient has known or active hepatitis B or hepatitis C 20. History or presence of conditions that may place the patient at increased risk as determined by the investigator. 21. Has taken other investigational drugs or participated in any clinical study within 30 days or 5 half-lives (if known) of the investigational drugââ?¬•s PK, PD, or biological activity (if known), whichever is longer, prior to first dose of study drug in this study or is currently participating in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Endpoint: Proportion of patients showing 2 points improvement as per WHO ordinal scale and mortality after 14 days of treatment. Safety Endpoints: Incidence of new bacterial, fungal, or opportunistic infection Incidence of Grade 4 neutropenia (absolute neutrophil count [ANC] less than 500 per mm3) Incidence of Grade 3-4 adverse events ([AEs]; clinical orlaboratory) Incidence of serious adverse events (SAEs) Incidence of abnormal electrocardiograms (ECGs) requiring clinical action 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. Timepoint: PD Blood Collection on Day 01, 04, 08, 15, 29, 58. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Endpoint: Improvement after completion of treatment of Day 7, 10, 21 and Day 28 (average individual change from baseline for COVID-19 WHO Ordinal Scale for Clinical Improvement) Proportion of patients alive and without respiratory failure at Day 29 of treatment (after 28 days of treatment) Mean vital signs summary score on Days 4, 8, 15, 22, and 29 (average individual change from baseline) Days in hospital to discharge Timepoint: PD Blood Collection on Day 01, 04, 08, 15, 29, 58. | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research LLP
Outcome results
None listed