COVID Clinical Trial
Official title:
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Axatilimab for the Treatment of Hospitalized Patients With Respiratory Signs and Symptoms Secondary to Novel Coronavirus Disease (COVID-19)
This was a randomized, double-blind, placebo-controlled, 29-day study to assess the efficacy and safety of axatilimab plus standard of care (SOC), compared with placebo plus SOC, in participants with respiratory signs and symptoms secondary to COVID-19.
Axatilimab (SNDX-6352) is a humanized immunoglobin G4 monoclonal antibody with high affinity against colony stimulating factor-1 receptor (CSF-1R) under investigation for the prevention or treatment of respiratory signs and symptoms secondary to COVID-19. This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety and tolerability of axatilimab as an add-on to SOC therapy in hospitalized participants with respiratory signs and symptoms secondary to COVID-19 compared to SOC treatment. Eligible participants were to be randomized in a 1:1 ratio to 1 of 2 treatment groups, active or control. All participants were to receive axatilimab or matching placebo intravenously (IV) as an add-on to SOC on Day 1, within 8 hours of randomization and on Day 15. Participants were to be followed for at least 28 days (+3 days) after the first dose of study intervention (Day 29). The primary objective of the study was to assess the proportion of participants alive and free of respiratory failure at Day 29. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04558125 -
Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism
|
Phase 4 | |
| Recruiting |
NCT04410510 -
P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04420676 -
Synbiotic Therapy of Gastrointestinal Symptoms During Covid-19 Infection
|
N/A | |
| Completed |
NCT04419025 -
Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease
|
Phase 2 | |
| Completed |
NCT04395911 -
Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections
|
N/A | |
| Completed |
NCT04425317 -
Detection of SARS-CoV-2 in Follicular Fluid and Cumulus-oocyte-complexes in COVID-19 Patients
|
N/A | |
| Withdrawn |
NCT04456426 -
Characteristics of Patients With COVID-19 in Meta State, Colombia
|
||
| Completed |
NCT04526769 -
Detecting SARS-CoV-2 in Tears
|
||
| Completed |
NCT04425720 -
Use of Remote Monitoring for COVID-19 Patient
|
N/A | |
| Suspended |
NCT04385771 -
Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation
|
N/A | |
| Completed |
NCT04419610 -
RAS and Coagulopathy in COVID19
|
Early Phase 1 | |
| Completed |
NCT04546581 -
Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)
|
Phase 3 | |
| Terminated |
NCT04530448 -
Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization
|
Phase 4 | |
| Completed |
NCT04435327 -
Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19)
|
||
| Not yet recruiting |
NCT04524156 -
COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2
|
N/A | |
| Completed |
NCT04441710 -
Caregiver Serological Monitoring Extended Secondarily to Patients With the SARS-CoV-2 Coronavirus
|
||
| Completed |
NCT04357834 -
WAVE. Wearable-based COVID-19 Markers for Prediction of Clinical Trajectories
|
||
| Not yet recruiting |
NCT04392427 -
New Antiviral Drugs for Treatment of COVID-19
|
Phase 3 | |
| Terminated |
NCT04614025 -
Open-label Multicenter Study to Evaluate the Efficacy of PLX-PAD for the Treatment of COVID-19
|
Phase 2 | |
| Completed |
NCT04402957 -
LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)
|
Phase 2 |