Multicentric, Randomized Study to Assess Safety and Efficacy of Centhaquine in COVID-19 Patients With ARDS

Launched by PHARMAZZ, INC. · Feb 14, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a new treatment called Centhaquine for patients with severe COVID-19 who are experiencing Acute Respiratory Distress Syndrome (ARDS). ARDS can occur when the lungs become severely inflamed and fail to provide enough oxygen to the body, often requiring patients to be on ventilators in the intensive care unit. The study is looking for adult patients aged 18 and older who have been confirmed to have COVID-19, are currently hospitalized and intubated, and have specific low oxygen levels and blood pressure issues.

If you or a loved one is eligible for this trial, you will need to provide written consent to participate. Throughout the study, participants will receive either Centhaquine or standard treatment, and researchers will carefully monitor their health and recovery. This trial aims to find better treatment options for those with severe COVID-19, especially as new variants continue to emerge. Your involvement could help advance knowledge and treatment for others facing similar challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• A subject will be eligible for inclusion in the study if he/she fulfils the following criteria:
• • 1. Adult males or females aged 18 years or older
• • 2. RT-PCR confirmation for SARS-CoV2 infection from respiratory tract specimens)
• • 3. Currently hospitalized and intubated COVID-19 patients
• • 4. P/F ratio of \<100 mmHg with PEEP ≥ 5 cm H20
• • 5. Systolic blood pressure below 90 mmHg
• • 6. Written informed consent
• Exclusion Criteria:
• A subject will not be eligible for inclusion in this study if he/she meets any of the following exclusion criteria:
• • 1. Patients with confirmed pregnancy
• • 2. Breast feeding patients
• • 3. Patient is participating in another interventional study
• • 4. Patient developing ARDS due to fluid overload or congestive heart failure
• • 5. Patients with alternative causes of hypotension not related to COVID-19 (e.g., hypovolemia, neurogenic, iatrogenic)
• • 6. Patients with renal impairment (eGFR \< 60 ml/min/1.73 m2)
• • 7. Patients with hepatic impairment (Child Pugh scores B and C)