A Phase 2, Randomized, Double blind, Placebo-controlled, Two-arm Study to Evaluate the Efficacy and Safety of Hydroxyprogesterone Caproate Intramuscular Injection Plus Dexamethasone Compared to Dexamethasone Alone in Patients with Moderate COVID-19 disease (Non-intubated, Nonmechanical Ventilation).

Evergreen Therapeutics Inc7 个研究点分布在 1 个国家目标入组 44 人开始时间: 2021年12月30日最近更新: 2022年9月15日

试验速览

阶段: 2 期
状态: 招募中
发起方: Evergreen Therapeutics Inc
入组人数: 44
试验地点: 7
主要终点: Efficacy Endpoint: Proportion of patients showing 2 points improvement as per

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is aPhase 2, multi-site, randomized, double-blind, placebo controlled, two-armstudy to evaluate the efficacy and safety of EG009A IM injection in patientshospitalized with moderate COVID 19 infection as per ICMR guideline (WHOOrdinal Scale for Clinical improvement score of 5 [non-intubated andnon-mechanical ventilation]).

Patients withmoderate COVID-19 infection as per ICMR guidelines (WHO Ordinal Scale forClinical Improvement score of 5 [non intubated and not under mechanicalventilation]) will be eligible to participate in the study.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 45.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•Patients must meet all inclusion criteria to be eligible for study Participation.
•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
•Male or female patients aged between 45 to 60 years, both inclusive, with gender balance ensured through stratification upon randomization.
•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
•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.
•Vaccination status for COVID-19 will not influence eligibility for the study.
•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.
•Patient understands and agrees to comply with planned study procedures.
•Patient agrees to be placed on a prophylactic dose of anticoagulation medication for prevention of deep venous thrombosis (DVT) while hospitalized
•Patients who are women of childbearing potential must have a negative pregnancy test.

排除标准

•Patients will not be eligible for study participation if they meet any of the exclusion criteria.
•Patient has severe COVID-19 infection as per ICMR guideline (Respiratory rate >30/min, breathlessness or SpO2 < 90% on room air).
•Patients with WHO ordinal scale for clinical improvement severity scores 6 or 7 at baseline will be excluded.
•Patient is currently receiving extracorporeal membrane oxygenation (ECMO), nitric oxide therapy, or high-frequency oscillatory ventilation
•Patient is unlikely to survive for > 24 hours from randomization, in the opinion of the investigator
•Patient has a history of chronic oxygen use or any pre-existing respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
•Patient has a history of venous thromboembolism (VTE), DVT, or pulmonary embolus
•Patient has a malignancy of any type
•Patient has breast cancer or a history of breast cancer and now cancer free for < 5 years
•Patient has suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19)
•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— 109/L Platelets < 50 Ã— 109/L Alanine aminotransferase or aspartate aminotransferase > 5 Ã— upper limit of normal
•Patient is sharing a ventilator, or co-ventilating, with any other patient.
•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
•Patient has history of long-term use of antirejection or immunomodulatory drugs
•Patient is pregnant or lactating
•Patient has a known hypersensitivity to progesterone or DEX
•Patient is taking systemic corticosteroids for an indication other than COVID-19
•Patient has known or active human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome (AIDS) infection
•Patient has known or active hepatitis B or hepatitis C
•History or presence of conditions that may place the patient at increased risk as determined by the investigator.
•Has taken other investigational drugs or participated in any clinical study within 30 days or 5 half-lives (if known) of the investigational drugâ€™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.