COVID-19Phase 2PRANANCT04458298
A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients
A Phase 2 study testing OP-101 in people with COVID-19, run by Ashvattha Therapeutics, Inc. at 8 sites in United States.
Trial summary
The primary purpose of Stage-I of this study is to evaluate the safety and tolerability of OP-101 in patients with severe COVID-19 and of Stage 2 of this study is to evaluate the efficacy of OP-101 in patients with severe COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- OP-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 8 sitesUnited States
- Study dates
- 11 Aug 2020to 12 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage I:
- Body mass index (BMI) less than or equal to (<=) 35 kilogram per meter square (kg/m^2)
- Positive laboratory test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or respiratory infection with recent exposure to a person with laboratory-proven SARS-CoV-2
- Patient has an ordinal scale score between 5 and 7, inclusive, using the WHO 7OS
- Hypoxemia defined by saturation of peripheral oxygen (SpO2) of less than (<) 95 percent (%) on room air or Acute respiratory distress syndrome (ARDS)
- Occurrence of at least two of the following criteria: fever greater than (>) 38.0 degree celsius, tachycardia >90 beats/minute, tachypnea >20 breaths/minute, leucocytosis >12*109 per liter (/L) or leucopoenia <4 *10^9/L
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- Enrollment must occur within 72 hours from the initiation of mechanical ventilation or high-flow oxygen
- A signed informed consent form (ICF) from the patient or the patient's legally authorized representative must be available (telephone consent is acceptable)
- Female patients may not be pregnant, lactating, or breastfeeding
- Female patients of childbearing potential must have negative result for pregnancy test at screening
- Male patients must agree to use a barrier method of contraception during the study and for 90 days after the last dose
- Participants must have an estimated glomerular filtration rate of greater than or equal to (>=) 45 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2) at screening
- Must agree not to enroll in another study of an investigational agent prior to completion of this study.
- Stage II:
- Positive laboratory test for SARS-CoV-2 or respiratory infection with recent exposure to a person with laboratory-proven SARS-CoV-2
- Patient has an ordinal scale score between 5 and 8, inclusive, using the WHO 10OS.
- Patients with an ordinal score of 5 must be receiving oxygen by mask at a rate of 10 L or greater
- Hypoxemia defined by SpO2 of <95% on room air or diagnosed with ARDS
- Hyperinflammation (elevated CRP > upper limit of local normal for laboratory range) at screening
- A signed ICF from the patient or the patient's legally authorized representative must be available (telephone consent is acceptable)
- Female patients may not be pregnant, lactating, or breastfeeding
- Female patients of childbearing potential must have negative result for pregnancy test at screening
- Patients must have an estimated glomerular filtration rate of >= 30 mL/min/1.73 m^2 at screening
- Male patients must agree to use a barrier method of contraception during the study and for 90 days after the last dose
- Must agree not to enroll in another study of an investigational agent prior to completion of this study.
Who cannot join
- Stage I:
- Not expected to survive for more than 24 hours
- Underlying clinical condition where, in the opinion of the investigator, it would be extremely unlikely that the patient would come off ventilation (eg, motor neuron disease, Duchenne muscular dystrophy, or rapidly progressive interstitial pulmonary fibrosis)
- Severe chronic obstructive pulmonary disease requiring long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure used solely for sleep-disordered breathing
- Congestive heart failure, defined as New York Heart Association Class IV
- Acute left ventricular failure or myocardial infarction
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- Currently receiving extracorporeal membrane oxygenation (ECMO) therapy
- Receiving renal dialysis therapy for chronic renal failure
- Moderate to severe liver failure (Childs-Pugh Score >12)
- Presence of any active malignancy (other than nonmelanoma skin cancer) that required treatment within the last 2 years
- Lung transplant patient
- WHO Class III or IV pulmonary hypertension
- Documented deep venous thrombosis or pulmonary embolism within past 3 months
- Major trauma in the preceding 5 days
- Concurrent treatment with immune modulatory study drugs (e.g., anti-IL6 antibodies, Janus kinase (JAK) kinase inhibitors) or other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 within 30 days or 5 half-lives, whichever is longer, prior to dosing with OP-101; except for those that have received FDA emergency-use authorization and have become standard of care (SOC). Concurrent treatment with corticosteroids is permitted if participant has documented continued hypoxemia (SpO2 of <95% on room air) and hyper-inflammation (CRP>=10 mg/L) at screening.
- Has lost or donated >450 mL of whole blood or blood products within 30 days before screening
- Has any finding that, in the view of the investigator or medical monitor, would compromise the patient's safety requirements
- Is employed by the Sponsor, the contract research organization, or the study site (permanent, temporary contract worker, or designee responsible for the conduct of the study), or is a family member (spouse, parent, sibling, or child) of the Sponsor, contract research organization, or study site employee.
- Stage II:
- Not expected to survive for more than 24 hours
- Underlying clinical condition where, in the opinion of the investigator, it would be extremely unlikely that the patient would come off ventilation (e.g., motor neuron disease, Duchenne muscular dystrophy, or rapidly progressive interstitial pulmonary fibrosis)
- Severe chronic obstructive pulmonary disease requiring long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure used solely for sleep-disordered breathing
- Congestive heart failure, defined as New York Heart Association Class IV
- Acute left ventricular failure or myocardial infarction
- Currently receiving ECMO therapy
- Receiving renal dialysis therapy for end stage renal disease
- Moderate to severe liver failure (Childs-Pugh Score >12)
- Presence of any active malignancy (other than nonmelanoma skin cancer) that required treatment within the last 2 years
- Lung transplant patient
- WHO Class III or IV pulmonary hypertension
- Documented deep venous thrombosis or pulmonary embolism within past 3 months
- Major trauma in the preceding 5 days
- Concurrent treatment with approved or emergency use authorized immune modulatory study drugs (eg, anti-IL6 antibodies [tocilizumab], JAK kinase inhibitors [baricitinib]) or other investigational agents with actual or possible direct acting antiviral activity against SARS-CoV-2 within 30 days or 5 half-lives, whichever is longer, before dosing with OP-101.
- Has lost or donated >450 mL of whole blood or blood products within 30 days before screening
- Mechanical ventilation for >72 hours at the time of dosing
- Has any finding that, in the view of the investigator or medical monitor, would compromise the patient's safety requirements
- Is employed by the Sponsor, the contract research organization, or the study site (permanent, temporary contract worker, or designee responsible for the conduct of the study), or is a family member (spouse, parent, sibling, or child) of the Sponsor, contract research organization, or study site employee.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Research Site
Amarillo, Texas, 79109
Research Site
Atlanta, Georgia, 30342
Research site
Baltimore, Maryland, 21287
Research site
Fort Lauderdale, Florida, 33316
Research Site
Houston, Texas, 77030
Research site
Jacksonville, Florida, 32209
Research Site
Loma Linda, California, 92354
Research Site
Sioux Falls, South Dakota, 57105
About this study
Official title: A Two-Stage, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of OP-101 (Dendrimer N-acetyl-cysteine) in Patients With Severe COVID-19
The primary purpose of Stage-I of this study is to evaluate the safety and tolerability of OP-101 in patients with severe COVID-19 and of Stage 2 of this study is to evaluate the efficacy of OP-101 in patients with severe COVID-19.
The secondary purpose of Stage 1 and Stage 2 of this study is to determine the effect of OP-101 reducing proinflammatory cytokines biomarkers in severe COVID-19 Patients.
A further secondary objective of Stage 2 of this study is:
To evaluate the safety and tolerability of OP-101 in patients with severe COVID-19.
- Conditions
- COVID-19
- Being tested
- OP-101, Placebo
- Keywords
- SARS-COV-2, Coronavirus, Cytokine storm, Acute respiratory distress syndrome, Inflammation, IL-6, Treatment, OP-101
- Medical subject headings
- COVID-19, Coronavirus Infections, Cytokine Release Syndrome, Respiratory Distress Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OP-101Drug
OP-101 infusion will be administered intravenously.
PlaceboDrug
Matching placebo infusion will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Stage I: Cohort A: OP-101 2 mg/kg | Experimental | Participants will receive a single intravenous (IV) infusion of OP-101 2 milligram per kilogram (mg/kg) on Day 1. Receives: Drug: OP-101 |
| Stage I: Cohort B: OP-101 4 mg/kg | Experimental | Participants will receive a single IV infusion of OP-101 4 mg/kg on Day 1. Receives: Drug: OP-101 |
| Stage I: Cohort C: OP-101 8 mg/kg | Experimental | Participants will receive a single IV infusion of OP-101 8 mg/kg on Day 1. Receives: Drug: OP-101 |
| Stage I: Cohort D: Placebo | Placebo comparator | Participants will receive a single IV infusion of matching placebo on Day 1. Receives: Drug: Placebo |
| Stage II: Cohort E: OP-101 8 mg/kg | Experimental | Participants will receive a single IV infusion of OP-101 8 mg/kg on Days 1 and 4. Receives: Drug: OP-101 |
| Stage II: Cohort F: Placebo | Placebo comparator | Participants will receive a single IV infusion of matching placebo on Days 1 and 4. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage I: Number of Participants with Treatment Emergent Adverse Events Graded as Assessed by CTCAE Version 4.0
Number of participants with treatment emergent adverse events will be evaluated as a measure of safety and tolerability of OP-101 by monitoring and documenting all adverse events, which include laboratory test variables.
Measured: Up to Day 60
Stage II: Percentage of Participants Who Were Alive (i.e., not died due to any reason) at Day 29
Measured: Day 29
Secondary outcomes (21)
Stage I: Time to Improvement (2 points) in Clinical Status Assessment Using the World Health Organization 7-Point Ordinal Scale (WHO 7OS)
WHO-7 is a 7 point ordinal scale for clinical improvement with scores ranging from 0 to 7 where 0= uninfected, 1= no limitation of activities (ambulatory), 2= limitation of activities (ambulatory), 3= hospitalized, no oxygen therapy (hospitalized mild disease), 4= Hospitalized, oxygen by mask or nasal prongs (hospitalized mild disease), 5= Hospitalized, noninvasive ventilation or high-flow oxygen (hospitalized severe disease), 6= Hospitalized, intubation and mechanical ventilation (hospitalized severe disease), 7= Hospitalized, ventilation + additional organ support - pressors, renal replacement therapy, ECMO.
Measured: Up to Day 30
Stage I: Time to Resolution of Fever for at least 48 hours Without Antipyretics for Patients with Documented Fever (>=37.2 degree celsius [oral], or >=37.8 degree celsius [rectal], or >=38.0 degree celsius [tympanic])
Measured: Up to Day 30
Stage I: Time to Improvement in Oxygenation for at least 48 hours
Improvement in oxygenation is defined by increase in pulse oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) of >=50 compared with nadir SpO2/FiO2.
Measured: Up to Day 30
Stage I: Change from Baseline in the World Health Organization (WHO)-7 Point Ordinal Scale
WHO-7 is a 7 point ordinal scale for clinical improvement with scores ranging from 0 to 7 where 0= uninfected, 1= no limitation of activities (ambulatory), 2= limitation of activities (ambulatory), 3= hospitalized, no oxygen therapy (hospitalized mild disease), 4= Hospitalized, oxygen by mask or nasal prongs (hospitalized mild disease), 5= Hospitalized, noninvasive ventilation or high-flow oxygen (hospitalized severe disease), 6= Hospitalized, intubation and mechanical ventilation (hospitalized severe disease), 7= Hospitalized, ventilation + additional organ support - pressors, renal replacement therapy, ECMO.
Measured: Baseline up to Day 30
Stage I: Time to Discharge from Clinic or Hospital or to National Early Warning Score 2 (NEWS2) of <=2 and maintained for 24 hours
NEWS2 consists of: Physiological Parameters: Respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), Use of Air or oxygen, Systolic blood pressure (mmHg), Pulse (per minute), Consciousness, Temperature (°C).
Measured: Up to Day 30
Stage I: Percentage of Patients Alive and not Using Supplemental Oxygen at Time of Discharge from Hospital/Clinic or Day 30
Measured: Up to Day 30
Stage I: Number of Days of Resting Respiratory Rate of more than 24 breath/min
Measured: Up to Day 30
Stage I: Number of Days with Hypoxemia
Hypoxemia is defined by Saturation of Peripheral Oxygen (SpO2) of less than (<) 95 percent (%) on room air or acute respiratory distress syndrome (ARDS).
Measured: Up to Day 30
Stage I: Number of Days of Supplemental Oxygen use
Measured: Up to Day 30
Stage I: Number of Ventilator-free Days
Measured: Up to Day 28
Stage I: Number of Days in Intensive Care Unit (ICU)
Measured: Up to Day 30
Stage I: Number of Days of Hospitalization for Survivors
Measured: Up to Day 30
Stage I: Number of Participants with all cause Deaths
Measured: Up to Day 30
Stage I: Percent Change from Baseline in Proinflammatory Cytokines
Percent change from baseline in proinflammatory cytokines (C-reactive protein [CRP], ferritin, and interleukin-6 [IL-6]) will be reported.
Measured: Baseline up to Day 30
Stage I: Incidence of Drug-related Serious Adverse Events (SAEs)
Measured: Up to Day 60
Stage II: Percentage of Participants Who Were Alive and free of Respiratory Failure
Respiratory failure is defined as at least 1 of the following: i. Endotracheal intubation and mechanical ventilation; ii. Oxygen delivered by high-flow nasal cannula (>20 L/minute; >=50% oxygen) OR fraction of inspired oxygen >50% delivered by Face Mask, Venturi, Rebreather Mask, Oxymizer Mask; iii. Non-invasive positive pressure oxygen - Continuous Positive Airway Pressure (CPAP) use for chronic sleep apnea treatment is not included in the definition of respiratory failure; iv. Extracorporeal membrane oxygenation (ECMO).
Measured: Up to Day 29
Stage II: Percentage of Participants Alive and Free of Invasive Mechanical Ventilation
Measured: Up to Day 29
Stage II: Percentage of Participants Alive and Discharged From the Hospital
Measured: Up to Day 29
Stage II: Percentage of Participants Alive and not Using Supplemental Oxygen at Time of Discharge from Hospital/Clinic or Day 29
Measured: Up to Day 29
Stage II: Percent Change from Baseline in Proinflammatory Biomarkers
Percent change from baseline in proinflammatory cytokines (CRP, ferritin, IL-6, and serum neurofilament light chain [sNfL]) will be reported.
Measured: Baseline up to Day 29
Stage II: Number of Days in Intensive Care Unit (ICU)
Measured: Up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start11 Aug 2020
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ashvattha Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458298
- Sponsor's protocol ID
- OP-101-004
- Acronym
- PRANA
- Status last verified
- Feb 2023
- First submitted
- 29 Jun 2020
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Stage, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of OP-101 (Dendrimer N-acetyl-cysteine) in Patients With Severe COVID-19
- ClinicalTrials.gov ID
- NCT04458298
- Acronym / sponsor ID
- PRANA / OP-101-004
- Conditions
- COVID-19
- Keywords
- SARS-COV-2, Coronavirus, Cytokine storm, Acute respiratory distress syndrome, Inflammation, IL-6, Treatment, OP-101
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ashvattha Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of Stage-I of this study is to evaluate the safety and tolerability of OP-101 in patients with severe COVID-19 and of Stage 2 of this study is to evaluate the efficacy of OP-101 in patients with severe COVID-19.
The secondary purpose of Stage 1 and Stage 2 of this study is to determine the effect of OP-101 reducing proinflammatory cytokines biomarkers in severe COVID-19 Patients.
A further secondary objective of Stage 2 of this study is:
To evaluate the safety and tolerability of OP-101 in patients with severe COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Stage I: Cohort A: OP-101 2 mg/kg | Experimental | Drug: OP-101Participants will receive a single intravenous (IV) infusion of OP-101 2 milligram per kilogram (mg/kg) on Day 1. |
| Stage I: Cohort B: OP-101 4 mg/kg | Experimental | Drug: OP-101Participants will receive a single IV infusion of OP-101 4 mg/kg on Day 1. |
| Stage I: Cohort C: OP-101 8 mg/kg | Experimental | Drug: OP-101Participants will receive a single IV infusion of OP-101 8 mg/kg on Day 1. |
| Stage I: Cohort D: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single IV infusion of matching placebo on Day 1. |
| Stage II: Cohort E: OP-101 8 mg/kg | Experimental | Drug: OP-101Participants will receive a single IV infusion of OP-101 8 mg/kg on Days 1 and 4. |
| Stage II: Cohort F: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single IV infusion of matching placebo on Days 1 and 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Body mass index (BMI) less than or equal to (<=) 35 kilogram per meter square (kg/m^2)
- Positive laboratory test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or respiratory infection with recent exposure to a person with laboratory-proven SARS-CoV-2
- Patient has an ordinal scale score between 5 and 7, inclusive, using the WHO 7OS
- Hypoxemia defined by saturation of peripheral oxygen (SpO2) of less than (<) 95 percent (%) on room air or Acute respiratory distress syndrome (ARDS)
- Occurrence of at least two of the following criteria: fever greater than (>) 38.0 degree celsius, tachycardia >90 beats/minute, tachypnea >20 breaths/minute, leucocytosis >12*109 per liter (/L) or leucopoenia <4 *10^9/L
Key exclusion criteria (37 listed)
- Not expected to survive for more than 24 hours
- Underlying clinical condition where, in the opinion of the investigator, it would be extremely unlikely that the patient would come off ventilation (eg, motor neuron disease, Duchenne muscular dystrophy, or rapidly progressive interstitial pulmonary fibrosis)
- Severe chronic obstructive pulmonary disease requiring long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure used solely for sleep-disordered breathing
- Congestive heart failure, defined as New York Heart Association Class IV
- Acute left ventricular failure or myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OP-101OP-101 infusion will be administered intravenously. | Drug | Stage I: Cohort A: OP-101 2 mg/kg, Stage I: Cohort B: OP-101 4 mg/kg, Stage I: Cohort C: OP-101 8 mg/kg, Stage II: Cohort E: OP-101 8 mg/kg |
| PlaceboMatching placebo infusion will be administered intravenously. | Drug | Stage I: Cohort D: Placebo, Stage II: Cohort F: Placebo |
Primary outcome
Stage I: Number of Participants with Treatment Emergent Adverse Events Graded as Assessed by CTCAE Version 4.0
Time frame: Up to Day 60
Number of participants with treatment emergent adverse events will be evaluated as a measure of safety and tolerability of OP-101 by monitoring and documenting all adverse events, which include laboratory test variables.
Stage II: Percentage of Participants Who Were Alive (i.e., not died due to any reason) at Day 29
Time frame: Day 29
21 secondary outcomes
Stage I: Time to Improvement (2 points) in Clinical Status Assessment Using the World Health Organization 7-Point Ordinal Scale (WHO 7OS)
Time frame: Up to Day 30
Stage I: Time to Resolution of Fever for at least 48 hours Without Antipyretics for Patients with Documented Fever (>=37.2 degree celsius [oral], or >=37.8 degree celsius [rectal], or >=38.0 degree celsius [tympanic])
Time frame: Up to Day 30
Stage I: Time to Improvement in Oxygenation for at least 48 hours
Time frame: Up to Day 30
Stage I: Change from Baseline in the World Health Organization (WHO)-7 Point Ordinal Scale
Time frame: Baseline up to Day 30
Stage I: Time to Discharge from Clinic or Hospital or to National Early Warning Score 2 (NEWS2) of <=2 and maintained for 24 hours
Time frame: Up to Day 30
Stage I: Percentage of Patients Alive and not Using Supplemental Oxygen at Time of Discharge from Hospital/Clinic or Day 30
Time frame: Up to Day 30
Stage I: Number of Days of Resting Respiratory Rate of more than 24 breath/min
Time frame: Up to Day 30
Stage I: Number of Days with Hypoxemia
Time frame: Up to Day 30
Stage I: Number of Days of Supplemental Oxygen use
Time frame: Up to Day 30
Stage I: Number of Ventilator-free Days
Time frame: Up to Day 28
Stage I: Number of Days in Intensive Care Unit (ICU)
Time frame: Up to Day 30
Stage I: Number of Days of Hospitalization for Survivors
Time frame: Up to Day 30
Stage I: Number of Participants with all cause Deaths
Time frame: Up to Day 30
Stage I: Percent Change from Baseline in Proinflammatory Cytokines
Time frame: Baseline up to Day 30
Stage I: Incidence of Drug-related Serious Adverse Events (SAEs)
Time frame: Up to Day 60
Stage II: Percentage of Participants Who Were Alive and free of Respiratory Failure
Time frame: Up to Day 29
Stage II: Percentage of Participants Alive and Free of Invasive Mechanical Ventilation
Time frame: Up to Day 29
Stage II: Percentage of Participants Alive and Discharged From the Hospital
Time frame: Up to Day 29
Stage II: Percentage of Participants Alive and not Using Supplemental Oxygen at Time of Discharge from Hospital/Clinic or Day 29
Time frame: Up to Day 29
Stage II: Percent Change from Baseline in Proinflammatory Biomarkers
Time frame: Baseline up to Day 29
Stage II: Number of Days in Intensive Care Unit (ICU)
Time frame: Up to Day 29
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OP-101 in people with COVID-19, run by Ashvattha Therapeutics, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage I: Number of Participants with Treatment Emergent Adverse Events Graded as Assessed by CTCAE Version 4.0 (time frame: Up to Day 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.