COVIDPhase 1NCT04395716
A Study of ResCure™ to Treat COVID-19 Infection
A Phase 1 study testing ResCure™ in people with COVID and Covid-19, run by ProgenaBiome at 1 site in United States.
Trial summary
This is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Covid-19, Corona Virus Infection
- What is being tested?
- ResCure™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2020to Nov 2021
- Phase
- Phase 1
- 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
- Critically ill patients with SARS from COVID-19 infection on respirators OR
- Patients with SARS from COVID-19 infection prior or after being placed on respirator
- Male or female patients 18 years of age and older
Who cannot join
- 1. Patients less than 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of ResCure™ to Treat COVID-19 Infection
This is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection.
Read the detailed description
In this Phase I open-label interventional study we will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection. Patients being treated will have severe respiratory symptoms that are at or near requiring the patient be placed on a ventilator.
- Conditions
- COVID, Covid-19, Corona Virus Infection, Sars-CoV2, Coronavirus-19, SARS Pneumonia
- Being tested
- ResCure™
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResCure™Biological
Patients will be treated with nebulized ResCure™
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | This group will be treated with nebullized ResCure™ while hospitalized every 4 to 6 hours, depending on disease severity and ventilator status. Receives: Biological: ResCure™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of recovery of mild or moderate COVID-19 in patients using ResCure™
Number of days from COVID-19 diagnosis to recovery via RT-PCR
Measured: 12 Weeks
Reduction or progression of symptomatic days
Reduction and/or progression of symptomatic days, reduction of symptom severity
Measured: 12 Weeks
Assess the safety of ResCure™ via pulse
Pulse from baseline to 12 weeks
Measured: 12 Weeks
Assess the safety of ResCure™ via oxygen saturation
Oxygen saturation from baseline to 12 weeks
Measured: 12 Weeks
Assess the safety of ResCure™ via EKG
EKG from baseline to 12 weeks
Measured: 12 Weeks
Assess Tolerability of ResCure™
Assess Adverse Events and Serious Adverse Events due to ResCure™
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study startJan 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionNov 2021 (estimated)
Why it stopped: Not ever started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProgenaBiome
- Sponsor type
- University, hospital or other
- Collaborators
- Rinati Skin, LLC
- Responsible party
- Sponsor
- Investigators
- Sabine Hazan, MD, Principal investigator, ProgenaBiome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395716
- Sponsor's protocol ID
- PRG-048
- Status last verified
- Apr 2021
- First submitted
- 19 May 2020
- Last updated
- 8 Apr 2021
- 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of ResCure™ to Treat COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04395716
- Acronym / sponsor ID
- PRG-048
- Conditions
- COVID, Covid-19, Corona Virus Infection, Sars-CoV2, Coronavirus-19, SARS Pneumonia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not ever started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ProgenaBiomeUniversity, hospital or other
- Collaborators
- Rinati Skin, LLC
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 20 May 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.
This is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection.
Detailed description
In this Phase I open-label interventional study we will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection. Patients being treated will have severe respiratory symptoms that are at or near requiring the patient be placed on a ventilator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: ResCure™This group will be treated with nebullized ResCure™ while hospitalized every 4 to 6 hours, depending on disease severity and ventilator status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Critically ill patients with SARS from COVID-19 infection on respirators OR
- Patients with SARS from COVID-19 infection prior or after being placed on respirator
- Male or female patients 18 years of age and older
Key exclusion criteria (1 listed)
- 1. Patients less than 18 years of age
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 |
|---|---|---|
| ResCure™Patients will be treated with nebulized ResCure™ | Biological | Treatment Group |
Primary outcome
The rate of recovery of mild or moderate COVID-19 in patients using ResCure™
Time frame: 12 Weeks
Number of days from COVID-19 diagnosis to recovery via RT-PCR
Reduction or progression of symptomatic days
Time frame: 12 Weeks
Reduction and/or progression of symptomatic days, reduction of symptom severity
Assess the safety of ResCure™ via pulse
Time frame: 12 Weeks
Pulse from baseline to 12 weeks
Assess the safety of ResCure™ via oxygen saturation
Time frame: 12 Weeks
Oxygen saturation from baseline to 12 weeks
Assess the safety of ResCure™ via EKG
Time frame: 12 Weeks
EKG from baseline to 12 weeks
Assess Tolerability of ResCure™
Time frame: 12 Weeks
Assess Adverse Events and Serious Adverse Events due to ResCure™
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Sabine Hazan, MD principal investigator
ProgenaBiome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ResCure™ in people with COVID and Covid-19, run by ProgenaBiome at 1 site 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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 withdrawn before enrolling participants, so there are no results.
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?
The rate of recovery of mild or moderate COVID-19 in patients using ResCure™ (time frame: 12 Weeks). The study lists 6 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 8 Apr 2021.