COVID-19 Pneumonia Clinical Trial
Official title:
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of F-652 in Subjects With COVID-19 Pneumonia
This is a phase 2a, multicenter, randomized, double-blinded, placebo controlled, dose escalation study in adult subjects with COVID-19 pneumonia. The primary objective of this study is to evaluate the overall safety of F-652 in COVID subjects in order to identify safe dose(s) for future studies with adequate patient numbers to demonstrate clinical efficacy.
The study is planned to include 2 cohorts, with enrolled patients being randomized 2:1 in a blinded manner on Day 1, following screening, to F-652 or placebo as follows: - Cohort 1: subjects will receive up to two intravenous (IV) infusions of F-652 at dose 1 or placebo. Upon completion of Cohort 1, the data monitoring committee (DMC) will convene and review all available safety data to determine if the study can proceed to the next dose level. - Cohort 2: subjects will receive up to two IV infusions of F-652 at dose 2 or placebo. Approximately 60 eligible subjects will be enrolled in the study with 30 subjects per dose cohort. Each cohort will have about 20 subjects treated with F-652 and 10 subjects treated with matching placebo. All randomized subjects will receive standard-of-care treatments for COVID-19 per individual institution standards. Treatment will begin on Day 1 following randomization. Subjects will receive up to two IV infusions of F-652 or matching placebo. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Suspended |
NCT04901676 -
Leronlimab in Moderately Ill Patients With COVID-19 Pneumonia
|
Phase 3 | |
| Not yet recruiting |
NCT04534478 -
Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19
|
Phase 4 | |
| Active, not recruiting |
NCT05002517 -
Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of Tocilizumab
|
Phase 3 | |
| Completed |
NCT05008393 -
Efficacy of PJS-539 for Adult Patients With COVID-19.
|
Phase 2 | |
| Completed |
NCT04569877 -
GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia
|
Phase 2 | |
| Not yet recruiting |
NCT05286255 -
Mesenchymal Stromal Cells for COVID-19 and Viral Pneumonias
|
Phase 1 | |
| Not yet recruiting |
NCT05890573 -
Efficacy of Bailing Capsule on Pulmonary Fibrosis After COVID-19
|
N/A | |
| Completed |
NCT05035589 -
The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia
|
||
| Recruiting |
NCT06113432 -
CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study
|
N/A | |
| Recruiting |
NCT05042063 -
Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
|
||
| Recruiting |
NCT04615429 -
Clinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19
|
Phase 2 | |
| Completed |
NCT05047653 -
RALE Versus CORADS/CT-Severity Score in COVID-19
|
||
| Active, not recruiting |
NCT05047016 -
Study to Evaluate the Dynamic Consent Model Based on the Blockchain-based Clinical Trial Platform METORY
|
N/A | |
| Active, not recruiting |
NCT05033847 -
Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above
|
Phase 2 | |
| Recruiting |
NCT06113757 -
Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease
|
N/A | |
| Completed |
NCT05504655 -
N-Acetylcysteine as an Adjuvant Therapy in Critically Ill COVID-19 Patients:
|
||
| Active, not recruiting |
NCT05035524 -
A Randomized Controlled Trial to Investigate The Role of Adjuvant Inhalable Sodium Bicarbonate Solution 8.4% in Treatment of COVID-19
|
N/A | |
| Completed |
NCT05065879 -
Evaluation of Immunogenicity and Safety of COVID-19 Vaccine (Produced in Beijing) in Patients With Hypertension and/or Diabetes
|
Phase 4 | |
| Withdrawn |
NCT04390217 -
LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia
|
Phase 2 | |
| Withdrawn |
NCT04460105 -
Lanadelumab in Participants Hospitalized With COVID-19 Pneumonia
|
Phase 1 |