COVID-19ATTRACT-2NCT04878913
Retrospective Evaluation of Lung Pathology in Subjects With COVID-19
An observational study of COVID-19 and COVID-19 Pneumonia, run by Vicore Pharma AB at 4 sites in India.
Trial summary
Non-interventional, retrospective, multi-center, follow-up study evaluating the effect of C21 on lung pathology in subjects previously hospitalised with COVID-19 and enrolled in the VP-C21-006 trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19, COVID-19 Pneumonia
- What is being tested?
- C21
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 4 sitesIndia
- Study dates
- 7 Jul 2021to 23 Aug 2021
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who were previously hospitalized with COVID-19 and enrolled in the VP-C21-006 trial.
Who may be able to join
- Written informed consent
- Previously included in the VP-C21-006 trial and received at least one dose of investigational medicinal product (IMP)
- Available record of at least one HRCT performed within 24 weeks after completion of VP-C21-006.
Who cannot join
- Participation in another interventional trial during the historical period covered by this study that could interfere with the study objectives or evaluation
Trial locations and contacts
4 sites in 1 country.
India4 sites
Department of Medicine, Civil Hospital and B J Medical College
Ahmedabad, Gujarat, 380016
Department of Medicine, Government Medical College and Hospital
Nagpur, Maharashtra, 440003
Department of Medicine, Noble Hospitals Pvt. Ltd
Pune, Maharashtra
First Floor Clinical Research Department Rhythm Heart Institute
Vadodara, Gujarat, 290022
About this study
Official title: Non-interventional, Retrospective, Multicenter, Follow-up Study Evaluating the Effect of C21 on Lung Pathology in Subjects Previously Hospitalized With COVID-19 and Enrolled in the VP-C21-006 Trial
Non-interventional, retrospective, multi-center, follow-up study evaluating the effect of C21 on lung pathology in subjects previously hospitalised with COVID-19 and enrolled in the VP-C21-006 trial.
Read the detailed description
The study will collect available HRCT scans obtained prior to, during treatment with C21 or placebo and up to 24 weeks after trial completion.
HRCT scans will be assessed for ground glass opacity, reticulation, band opacity, fibrosis and consolidation by a central, blinded HRCT reader.
- Conditions
- COVID-19, COVID-19 Pneumonia
- Being tested
- C21, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C21Drug
Also called Buloxibutid, Compound 21
C21 was administered in the VP-C21-006 trial
PlaceboDrug
Placebo was administered in the VP-C21-006 trial
| Study group | Role | What they receive |
|---|---|---|
| C21 | Participants treated with C21 in the VP-C21-006 trial Receives: Drug: C21 | |
| Placebo | Participants treated with placebo in the VP-C21-006 trial Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Averaged total lung score for both lungs percent measured by per lung percent scores
Based on ground glass opacity, reticulation, band opacity, fibrosis, and consolidation, on HRCT
Measured: Up to 24 weeks after completion of VP-C21-006
Change from baseline in percent lung involvement measured totally (averaged total lung score for both lungs percent) and by each of ground glass opacity, reticulation, band opacity, fibrosis, and consolidation on follow-up HRCT
Measured: Up to 24 weeks after completion of VP-C21-006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start7 Jul 2021
- Primary completion23 Aug 2021
- Study completion23 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vicore Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rohit Batta, MD, Study director, Vicore Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878913
- Sponsor's protocol ID
- VP-C21-007
- Acronym
- ATTRACT-2
- Status last verified
- Aug 2024
- First submitted
- 4 May 2021
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tornling G, et al. The angiotensin type 2 receptor agonist C21 restores respiratory function in COVID19 - a double-blind, randomized, placebo-controlled Phase 2 trial, medRxiv, 2021
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional, Retrospective, Multicenter, Follow-up Study Evaluating the Effect of C21 on Lung Pathology in Subjects Previously Hospitalized With COVID-19 and Enrolled in the VP-C21-006 Trial
- ClinicalTrials.gov ID
- NCT04878913
- Acronym / sponsor ID
- ATTRACT-2 / VP-C21-007
- Conditions
- COVID-19, COVID-19 Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Vicore Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 23 Aug 2021 (actual)
- First posted
- 10 May 2021 (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.
Non-interventional, retrospective, multi-center, follow-up study evaluating the effect of C21 on lung pathology in subjects previously hospitalised with COVID-19 and enrolled in the VP-C21-006 trial.
Detailed description
The study will collect available HRCT scans obtained prior to, during treatment with C21 or placebo and up to 24 weeks after trial completion.
HRCT scans will be assessed for ground glass opacity, reticulation, band opacity, fibrosis and consolidation by a central, blinded HRCT reader.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C21 | – | Drug: C21Participants treated with C21 in the VP-C21-006 trial |
| Placebo | – | Drug: PlaceboParticipants treated with placebo in the VP-C21-006 trial |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who were previously hospitalized with COVID-19 and enrolled in the VP-C21-006 trial.
Key inclusion criteria (3 listed)
- Written informed consent
- Previously included in the VP-C21-006 trial and received at least one dose of investigational medicinal product (IMP)
- Available record of at least one HRCT performed within 24 weeks after completion of VP-C21-006.
Key exclusion criteria (1 listed)
- Participation in another interventional trial during the historical period covered by this study that could interfere with the study objectives or evaluation
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 |
|---|---|---|
| C21Also: Buloxibutid, Compound 21C21 was administered in the VP-C21-006 trial | Drug | C21 |
| PlaceboPlacebo was administered in the VP-C21-006 trial | Drug | Placebo |
Primary outcome
Averaged total lung score for both lungs percent measured by per lung percent scores
Time frame: Up to 24 weeks after completion of VP-C21-006
Based on ground glass opacity, reticulation, band opacity, fibrosis, and consolidation, on HRCT
Change from baseline in percent lung involvement measured totally (averaged total lung score for both lungs percent) and by each of ground glass opacity, reticulation, band opacity, fibrosis, and consolidation on follow-up HRCT
Time frame: Up to 24 weeks after completion of VP-C21-006
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- BackgroundTornling G, et al. The angiotensin type 2 receptor agonist C21 restores respiratory function in COVID19 - a double-blind, randomized, placebo-controlled Phase 2 trial, medRxiv, 2021
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Rohit Batta, MD study director
Vicore Pharma
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and COVID-19 Pneumonia, run by Vicore Pharma AB at 4 sites in India.
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: finished, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Averaged total lung score for both lungs percent measured by per lung percent scores (time frame: Up to 24 weeks after completion of VP-C21-006). 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?
On the ClinicalTrials.gov record for NCT04878913, which also lists 1 linked publication.
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 4 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.