Back to resultsA Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
Primary Purpose
COVID, Covid-19, Coronavirus
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
APL-9
Vehicle Control
Sponsored by
About this trial
This is an interventional treatment trial for COVID
Eligibility Criteria
Inclusion Criteria:
- Be at least 18 years of age at time of informed consent
- Diagnosis of active SARS CoV 2 infection using viral RNA or viral antigen within 7 days of screening
- Respiratory failure requiring oxygen supplementation or either invasive or noninvasive mechanical ventilation with PaO2/FiO2 ratio >100 mm Hg. Respiratory failure cannot be fully explained by cardiac failure or fluid overload.
Exclusion Criteria:
- Treatment with immune checkpoint inhibitors, or other immunomodulators within 3 months prior to study enrollment (however, treatment with convalescent plasma, steroids, IL-6 inhibitors, and antiviral agents is NOT excluded)
- Active bacterial, fungal, or parasitic infection
- History of neuromuscular degenerative disease (eg, amyotrophic lateral sclerosis, Duchenne muscular dystrophy, or multiple sclerosis)
- Current participation in an interventional clincial trial
- Subjects who have, at screening, been on mechanical ventilation for >7 days Have evidence of kidney and liver failure at screening
- Have a hereditary complement deficiency
- Pregnancy or breastfeeding
Sites / Locations
- University of California at San Francisco - Fresno
- California Pacific Medical Center
- Baptist Medical Center Beaches
- Westchester General Hospital
- Northwestern University, Feinberg School of Medicine
- Loyola University Medical Center
- Lutheran Health Physicians
- University of Iowa Hospitals and Clinics
- Norton Women's and Children's Hospital
- Norton Audobon Hospital
- Cambridge Medical Trials
- Ascension Providence Hospital
- Rutgers University - Robert Wood Johnson Medical School
- University at Buffalo
- Columbia University
- Texas A&M College of Medicine - Scott and White
- Hospital Angelina Caron
- Irmandade da Santa Casa de Misericordia de Porto Alegre
- Hospital São Lucas da PUCRS
- Hospital Estadual Mario Covas
- CEMEC - Centro Multidisciplinar de Estudos Clinicos LTDA EPP
- Hospital Alemao Oswaldo Cruz
- Hospital Santa Marcelina
- UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
180 mg APL-9 IV plus SOC
Isotonic saline plus SOC
Arm Description
Outcomes
Primary Outcome Measures
Number of Subjects Who Experienced Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs were defined as those adverse events that developed or worsened in severity after initiation of the first dose of study drug and up to 30 (+7) days beyond the last dose of study drug. A serious TEAE was any TEAE or suspected adverse reaction that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes: death; is life threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or a congenital anomaly/birth defect.
Secondary Outcome Measures
Hospital Length of Stay
Hospital length of stay was defined as randomization date to hospital discharge. For subjects with death of any cause or withdrawal of study participation, hospital length of stay was imputed with the longest hospital length of stay observed in the study. Median hospital length of stay was estimated using the Kaplan-Meier method.
Overall Survival
Overall survival was defined as randomization date to death of any cause, censored at the last day known to be alive. Median overall survival was estimated using the Kaplan-Meier method.
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score Over Time
The SOFA score is an aggregate score based on objective measures of 6 organ systems: respiratory, coagulation, hepatic, cardiovascular, neurologic, and renal. The minimum value is 0 and maximum value is 24. Higher scores indicate worse outcomes. A subject with a SOFA score of zero was defined as being free of organ failure.
Total Duration of Mechanical Ventilation
Total duration of mechanical ventilation was calculated from the randomization date and was defined as days on mechanical ventilation during the study participation. For subjects with death of any cause (or withdrawal of study participation), total duration of mechanical ventilation was imputed with the longest duration observed in the study. Any subject who was not on mechanical ventilation at the randomization date was excluded. Median total duration of mechanical ventilation was estimated using the Kaplan-Meier method.
Total Duration of Oxygen Therapy
Total duration of oxygen therapy was calculated from randomization date and was defined as days on mechanical ventilation or supplemental oxygen during the study participation. For subjects with death of any cause (or withdrawal of study participation), total duration of oxygen therapy was imputed with the longest duration observed in the study. Any subject who was not on mechanical ventilation or supplemental oxygen at the randomization date was excluded. Median total duration of oxygen therapy was estimated using the Kaplan-Meier method.
Serum Concentration of APL-9 Over Time
To evaluate pharmacokinetics (PK), blood samples were collected at pre-specified timepoints and serum concentrations of APL-9 were determined. Blood was collected 3 times on Day 1: prior to the initial infusion, as soon as possible following the initial infusion (within 5-10 minutes) prior to the continuous infusion, and at 2 hours after the beginning of the continuous infusion. Blood was then collected once daily between 1-2 hours after the first dose on Days 3, 5, 7, 11 (if treatment was ongoing), Day 15 (if treatment was ongoing) and at the EOT visit.
Change From Baseline at EOT Visit in Biomarkers of Complement Activation: Components C3 and C4
To evaluate pharmacodynamic (PD) parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for complement biomarkers C3 and C4.
Change From Baseline at EOT Visit in Biomarkers of Complement Activation: Components C3a, C4a, C5a and Terminal Complement Complex (TCC)
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for complement biomarkers C3a, C4a, C5a and TCC.
Change From Baseline at EOT Visit in Biomarkers of Complement Activation: Complement Bb
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for complement biomarker Bb, a marker of alternative pathway activation.
Change From Baseline at EOT Visit in Biomarkers of Complement Activation: Alternative Complement Pathway Hemolytic Activity (AH50)
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for complement biomarker AH50.
Change From Baseline at EOT Visit in Biomarkers of Coagulopathy: Reticulocytes
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for the coagulation biomarker reticulocytes. Percentage (%) of reticulocytes was calculated as (Number of Reticulocytes / Number of Red Blood Cells) X 100.
Change From Baseline at EOT Visit in Biomarkers of Coagulopathy: Schistocytes
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for the coagulation biomarker schistocytes.
Change From Baseline at EOT Visit in Biomarkers of Coagulopathy: Lactate Dehydrogenase
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for the coagulation biomarker lactate dehydrogenase.
Change From Baseline at EOT Visit in Biomarkers of Coagulopathy: D-Dimer and Ferritin
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for the coagulation biomarkers D-dimer and ferritin.
Change From Baseline at EOT Visit in Biomarkers of Coagulopathy: Haptoglobin and Fibrinogen
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for the coagulation biomarkers haptoglobin and fibrinogen.
Change From Baseline at EOT Visit in Biomarkers of Inflammation: C-reactive Protein (CRP)
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for the inflammatory cytokine CRP.
Change From Baseline at EOT Visit in Biomarkers of Inflammation: Tumor Necrosis Factor Alpha (TNFα), Interleukin-1-beta (IL-1β) and Interleukin-6 (IL-6)
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for the inflammatory cytokines TNFα, IL-1β and IL-6.
Full Information
NCT ID
NCT04402060
First Posted
May 22, 2020
Last Updated
March 21, 2022
Sponsor
Apellis Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04402060
Brief Title
A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
Official Title
A Randomized, Double-Blinded, Vehicle-Controlled, Multicenter, Parallel-Group Study of APL-9 in Mild to Moderate Acute Respiratory Distress Syndrome Due to COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 28, 2020 (Actual)
Primary Completion Date
February 13, 2021 (Actual)
Study Completion Date
February 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apellis Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of APL-9 in adults with mild to moderate ARDS (acute respiratory distress syndrome) caused by COVID-19 who are hospitalized and require supplemental oxygen therapy with or without mechanical ventilation.
It is thought that COVID-19 activates the complement system, part of the immune system that responds to infection or tissue damage, and increases inflammation in the lungs. APL-9 has been designed to inhibit or block activation of part of the complement pathway, and potentially reduce inflammation in the lungs.
Part 1 of the study is open-label to evaluate safety; all participants will receive APL-9 plus standard of care. Part 2 of the study is double-blind, randomized; participants will receive either APL-9 or the vehicle-control plus standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Covid-19, Coronavirus, Coronavirus Infection, Severe Acute Respiratory Syndrome, Severe Acute Respiratory Syndrome Coronavirus 2, Sars-CoV2, Ards, Acute Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
180 mg APL-9 IV plus SOC
Arm Type
Experimental
Arm Title
Isotonic saline plus SOC
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
APL-9
Intervention Description
Complement (C3) Inhibitor
Intervention Type
Other
Intervention Name(s)
Vehicle Control
Intervention Description
Normal saline of equal volume to active arm
Primary Outcome Measure Information:
Title
Number of Subjects Who Experienced Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Description
TEAEs were defined as those adverse events that developed or worsened in severity after initiation of the first dose of study drug and up to 30 (+7) days beyond the last dose of study drug. A serious TEAE was any TEAE or suspected adverse reaction that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes: death; is life threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or a congenital anomaly/birth defect.
Time Frame
From the first dose of study drug and up to 30 (+7) days after the last dose of study drug. Part 1: Day 1 up to Day 44; Part 2: Day 1 up to Day 58
Secondary Outcome Measure Information:
Title
Hospital Length of Stay
Description
Hospital length of stay was defined as randomization date to hospital discharge. For subjects with death of any cause or withdrawal of study participation, hospital length of stay was imputed with the longest hospital length of stay observed in the study. Median hospital length of stay was estimated using the Kaplan-Meier method.
Time Frame
Part 2: Day 1 up to Day 58
Title
Overall Survival
Description
Overall survival was defined as randomization date to death of any cause, censored at the last day known to be alive. Median overall survival was estimated using the Kaplan-Meier method.
Time Frame
Part 2: Day 1 up to Day 58 (until the safety follow-up assessment 30 days after last study treatment [+7 days])
Title
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score Over Time
Description
The SOFA score is an aggregate score based on objective measures of 6 organ systems: respiratory, coagulation, hepatic, cardiovascular, neurologic, and renal. The minimum value is 0 and maximum value is 24. Higher scores indicate worse outcomes. A subject with a SOFA score of zero was defined as being free of organ failure.
Time Frame
Part 2: Baseline (Day 1) and Days 3, 5, 7, 11, 15 and end of treatment (EOT) visit (up to Day 21)
Title
Total Duration of Mechanical Ventilation
Description
Total duration of mechanical ventilation was calculated from the randomization date and was defined as days on mechanical ventilation during the study participation. For subjects with death of any cause (or withdrawal of study participation), total duration of mechanical ventilation was imputed with the longest duration observed in the study. Any subject who was not on mechanical ventilation at the randomization date was excluded. Median total duration of mechanical ventilation was estimated using the Kaplan-Meier method.
Time Frame
Part 2: Day 1 up to Day 58
Title
Total Duration of Oxygen Therapy
Description
Total duration of oxygen therapy was calculated from randomization date and was defined as days on mechanical ventilation or supplemental oxygen during the study participation. For subjects with death of any cause (or withdrawal of study participation), total duration of oxygen therapy was imputed with the longest duration observed in the study. Any subject who was not on mechanical ventilation or supplemental oxygen at the randomization date was excluded. Median total duration of oxygen therapy was estimated using the Kaplan-Meier method.
Time Frame
Part 2: Day 1 up to Day 58
Title
Serum Concentration of APL-9 Over Time
Description
To evaluate pharmacokinetics (PK), blood samples were collected at pre-specified timepoints and serum concentrations of APL-9 were determined. Blood was collected 3 times on Day 1: prior to the initial infusion, as soon as possible following the initial infusion (within 5-10 minutes) prior to the continuous infusion, and at 2 hours after the beginning of the continuous infusion. Blood was then collected once daily between 1-2 hours after the first dose on Days 3, 5, 7, 11 (if treatment was ongoing), Day 15 (if treatment was ongoing) and at the EOT visit.
Time Frame
Part 1: Day 1 (pre- and post-dose) and Days 3, 5 and 7 (including EOT visit); Part 2: Day 1 (pre- and post-dose) and Days 3, 5, 7, 11, 15 and EOT visit (up to Day 21)
Title
Change From Baseline at EOT Visit in Biomarkers of Complement Activation: Components C3 and C4
Description
To evaluate pharmacodynamic (PD) parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for complement biomarkers C3 and C4.
Time Frame
Part 1: Baseline (Day 1) and EOT visit (up to Day 7); Part 2: Baseline (Day 1) and EOT visit (up to Day 21)
Title
Change From Baseline at EOT Visit in Biomarkers of Complement Activation: Components C3a, C4a, C5a and Terminal Complement Complex (TCC)
Description
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for complement biomarkers C3a, C4a, C5a and TCC.
Time Frame
Part 1: Baseline (Day 1) and EOT visit (up to Day 7); Part 2: Baseline (Day 1) and EOT visit (up to Day 21)
Title
Change From Baseline at EOT Visit in Biomarkers of Complement Activation: Complement Bb
Description
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for complement biomarker Bb, a marker of alternative pathway activation.
Time Frame
Part 1: Baseline (Day 1) and EOT visit (up to Day 7); Part 2: Baseline (Day 1) and EOT visit (up to Day 21)
Title
Change From Baseline at EOT Visit in Biomarkers of Complement Activation: Alternative Complement Pathway Hemolytic Activity (AH50)
Description
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for complement biomarker AH50.
Time Frame
Part 1: Baseline (Day 1) and EOT visit (Day 7); Part 2: Baseline (Day 1) and EOT visit (up to Day 21)
Title
Change From Baseline at EOT Visit in Biomarkers of Coagulopathy: Reticulocytes
Description
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for the coagulation biomarker reticulocytes. Percentage (%) of reticulocytes was calculated as (Number of Reticulocytes / Number of Red Blood Cells) X 100.
Time Frame
Part 1: Baseline (Day 1) and EOT visit (Day 7); Part 2: Baseline (Day 1) and EOT visit (up to Day 21)
Title
Change From Baseline at EOT Visit in Biomarkers of Coagulopathy: Schistocytes
Description
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for the coagulation biomarker schistocytes.
Time Frame
Part 1: Baseline (Day 1) and EOT visit (Day 7); Part 2: Baseline (Day 1) and EOT visit (up to Day 21)
Title
Change From Baseline at EOT Visit in Biomarkers of Coagulopathy: Lactate Dehydrogenase
Description
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for the coagulation biomarker lactate dehydrogenase.
Time Frame
Part 1: Baseline (Day 1) and EOT visit (Day 7); Part 2: Baseline (Day 1) and EOT visit (up to Day 21)
Title
Change From Baseline at EOT Visit in Biomarkers of Coagulopathy: D-Dimer and Ferritin
Description
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for the coagulation biomarkers D-dimer and ferritin.
Time Frame
Part 1: Baseline (Day 1) and EOT visit (Day 7); Part 2: Baseline (Day 1) and EOT visit (up to Day 21)
Title
Change From Baseline at EOT Visit in Biomarkers of Coagulopathy: Haptoglobin and Fibrinogen
Description
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for the coagulation biomarkers haptoglobin and fibrinogen.
Time Frame
Part 1: Baseline (Day 1) and EOT visit (Day 7); Part 2: Baseline (Day 1) and EOT visit (up to Day 21)
Title
Change From Baseline at EOT Visit in Biomarkers of Inflammation: C-reactive Protein (CRP)
Description
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for the inflammatory cytokine CRP.
Time Frame
Part 1: Baseline (Day 1) and EOT visit (Day 7); Part 2: Baseline (Day 1) and EOT visit (up to Day 21)
Title
Change From Baseline at EOT Visit in Biomarkers of Inflammation: Tumor Necrosis Factor Alpha (TNFα), Interleukin-1-beta (IL-1β) and Interleukin-6 (IL-6)
Description
To evaluate PD parameters, blood samples were collected at pre-specified timepoints. Results are presented for change from baseline to EOT visit for the inflammatory cytokines TNFα, IL-1β and IL-6.
Time Frame
Part 1: Baseline (Day 1) and EOT visit (Day 7); Part 2: Baseline (Day 1) and EOT visit (up to Day 21)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be at least 18 years of age at time of informed consent
Diagnosis of active SARS CoV 2 infection using viral RNA or viral antigen within 7 days of screening
Respiratory failure requiring oxygen supplementation or either invasive or noninvasive mechanical ventilation with PaO2/FiO2 ratio >100 mm Hg. Respiratory failure cannot be fully explained by cardiac failure or fluid overload.
Exclusion Criteria:
Treatment with immune checkpoint inhibitors, or other immunomodulators within 3 months prior to study enrollment (however, treatment with convalescent plasma, steroids, IL-6 inhibitors, and antiviral agents is NOT excluded)
Active bacterial, fungal, or parasitic infection
History of neuromuscular degenerative disease (eg, amyotrophic lateral sclerosis, Duchenne muscular dystrophy, or multiple sclerosis)
Current participation in an interventional clincial trial
Subjects who have, at screening, been on mechanical ventilation for >7 days Have evidence of kidney and liver failure at screening
Have a hereditary complement deficiency
Pregnancy or breastfeeding
Facility Information:
Facility Name
University of California at San Francisco - Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Baptist Medical Center Beaches
City
Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32250
Country
United States
Facility Name
Westchester General Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
40241
Country
United States
Facility Name
Northwestern University, Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Lutheran Health Physicians
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Norton Women's and Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Norton Audobon Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Cambridge Medical Trials
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Ascension Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Rutgers University - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Texas A&M College of Medicine - Scott and White
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Hospital Angelina Caron
City
Campina Grande Do Sul
State/Province
Paraná
ZIP/Postal Code
83430-000
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Hospital São Lucas da PUCRS
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91530-001
Country
Brazil
Facility Name
Hospital Estadual Mario Covas
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09190-615
Country
Brazil
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clinicos LTDA EPP
City
São Bernardo Do Campo
State/Province
Sao Paulo
ZIP/Postal Code
0917-090
Country
Brazil
Facility Name
Hospital Alemao Oswaldo Cruz
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01323-020
Country
Brazil
Facility Name
Hospital Santa Marcelina
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
08270-120
Country
Brazil
Facility Name
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP
City
Botucatu
State/Province
São Paulo
ZIP/Postal Code
18618-686
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
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