COVID19SOCOVIDNCT04387292
Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
A study testing Ophthalmologic exam in people with COVID19 and Ophthalmopathy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Ophthalmologic damages secondary to COVID-19 coronavirus infection are little described. The ocular involvement is probably multiple, ranging from pathologies of the anterior segment such as conjunctivitis and anterior uveitis to disorders that threaten vision such as retinitis or optic neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19, Ophthalmopathy
- What is being tested?
- Ophthalmologic exam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2020to 15 May 2021
- Phase
- Interventional
- 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
- Patients having been hospitalized for a confirmed COVID-19 infection (CT-scanner or PCR- Polymerase chain reaction)
Who cannot join
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Ophthalmologic damages secondary to COVID-19 coronavirus infection are little described. The ocular involvement is probably multiple, ranging from pathologies of the anterior segment such as conjunctivitis and anterior uveitis to disorders that threaten vision such as retinitis or optic neuropathy. On the other hand, in addition to this impairment, when patients are hospitalized for acute respiratory failure, complications related to possible resuscitation, medication prescriptions, positioning and oxygenation.
COVID-19 itself, has several components:
- An apoptotic action of the viral attack which will generate cellular destruction, whether pulmonary, cardiac or renal or maybe ocular
- A secondary autoimmune action with the development of major vascular inflammation, possibly reaching the retinal, choroidal, and optic nerve vessels. A secondary "hyper" inflammatory syndrome with flashing hypercytokinemia and multi-organ decompensation is described in 3,7% to 4 ,3% of severe cases.
- A thromboembolic action
Read the detailed description
Upon discharge from hospital for COVID-19 infection (or during a telephone call for patients already discharged at the start of the study), patients will be informed of the study. An ophthalmology appointment will be given to them between 4 and 6 months after their discharge.
During the ophthalmology appointment, the patient's clinical data will be collected during an interview (medical and treatment history, blood group). The patient will benefit from a full ophthalmological examination.
- Conditions
- COVID19, Ophthalmopathy
- Being tested
- Ophthalmologic exam
- Keywords
- COVID19
- Medical subject headings
- COVID-19, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmologic examProcedure or surgery
- Visual acuity (ETDRS exam)
- Slit lamp examination : fluorescein test, Oxford score, break up time, Schirmer II test
- Lipiview
- Eye pressure measurement (air tonometer)
- Wide field retinophotography
- Multicolor and auto-fluorescence retinophotography
- Indocyanine green retinal angiography
- Optical coherence tomography (OCT) B posterior pole scan
- OCT Angiography (OCT-A) of the optic nerve and posterior pole
- Adaptive optics
- Visual field (Humphrey)
| Study group | Role | What they receive |
|---|---|---|
| Ophthalmologic exam | Experimental | Not described Receives: Procedure: Ophthalmologic exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the ophthalmological problems observed
Multimodal ophthalmologic imaging
Measured: 6 months after discharge of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start7 Sep 2020
- Primary completion21 Jan 2021
- Study completion15 May 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 COVID19Studies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Martine MAUGET FAYSSE, MD, Principal investigator, Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387292
- Sponsor's protocol ID
- MMT_2020_12
- Acronym
- SOCOVID
- Status last verified
- Aug 2021
- First submitted
- 12 May 2020
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdelmassih Y, Azar G, Bonnin S, Scemama Timsit C, Vasseur V, Spaide RF, Behar-Cohen F, Mauget-Faysse M. COVID-19 Associated Choroidopathy. J Clin Med. 2021 Oct 13;10(20):4686. doi: 10.3390/jcm10204686.
PubMed 34682810
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
- ClinicalTrials.gov ID
- NCT04387292
- Acronym / sponsor ID
- SOCOVID / MMT_2020_12
- Conditions
- COVID19, Ophthalmopathy
- Keywords
- COVID19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 13 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.
Ophthalmologic damages secondary to COVID-19 coronavirus infection are little described. The ocular involvement is probably multiple, ranging from pathologies of the anterior segment such as conjunctivitis and anterior uveitis to disorders that threaten vision such as retinitis or optic neuropathy. On the other hand, in addition to this impairment, when patients are hospitalized for acute respiratory failure, complications related to possible resuscitation, medication prescriptions, positioning and oxygenation.
COVID-19 itself, has several components:
- An apoptotic action of the viral attack which will generate cellular destruction, whether pulmonary, cardiac or renal or maybe ocular
- A secondary autoimmune action with the development of major vascular inflammation, possibly reaching the retinal, choroidal, and optic nerve vessels. A secondary "hyper" inflammatory syndrome with flashing hypercytokinemia and multi-organ decompensation is described in 3,7% to 4 ,3% of severe cases.
- A thromboembolic action
Detailed description
Upon discharge from hospital for COVID-19 infection (or during a telephone call for patients already discharged at the start of the study), patients will be informed of the study. An ophthalmology appointment will be given to them between 4 and 6 months after their discharge.
During the ophthalmology appointment, the patient's clinical data will be collected during an interview (medical and treatment history, blood group). The patient will benefit from a full ophthalmological examination.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ophthalmologic exam | Experimental | Procedure: Ophthalmologic exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having been hospitalized for a confirmed COVID-19 infection (CT-scanner or PCR- Polymerase chain reaction)
Key exclusion criteria (1 listed)
- Pregnant or breastfeeding woman
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 |
|---|---|---|
| Ophthalmologic exam* Visual acuity (ETDRS exam) * Slit lamp examination : fluorescein test, Oxford score, break up time, Schirmer II test * Lipiview * Eye pressure measurement (air tonometer) * Wide field retinophotography * Multicolor and auto-fluorescence retinophotography * Indocyanine green retinal angiography * Optical coherence tomography (OCT) B posterior pole scan * OCT Angiography (OCT-A) of the optic nerve and posterior pole * Adaptive optics * Visual field (Humphrey) | Procedure or surgery | Ophthalmologic exam |
Primary outcome
Description of the ophthalmological problems observed
Time frame: 6 months after discharge of hospitalization
Multimodal ophthalmologic imaging
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 6 Jan 2026.
- Results publication: PubMed 34682810Abdelmassih Y, Azar G, Bonnin S, Scemama Timsit C, Vasseur V, Spaide RF, Behar-Cohen F, Mauget-Faysse M. COVID-19 Associated Choroidopathy. J Clin Med. 2021 Oct 13;10(20):4686. doi: 10.3390/jcm10204686.
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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.
Martine MAUGET FAYSSE, MD principal investigator
Fondation A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ophthalmologic exam in people with COVID19 and Ophthalmopathy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 1 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 6 Jan 2026. 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 France. 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?
Description of the ophthalmological problems observed (time frame: 6 months after discharge of hospitalization). 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 NCT04387292, 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 6 Jan 2026.