COVID-19Phase 1/2SCARLETNCT05881135
Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET)
A Phase 1/2 study testing Citicoline in people with COVID-19, run by Ohio State University at 1 site in United States.
Trial summary
The goal of this single center, double-blinded, placebo-controlled, and randomized Phase 1 trial is to determine if i.v. citicoline is safe and efficacious compared to i.v. saline/control in adults presenting with SARS CoV-2 infection complicated by acute hypoxemic respiratory failure. 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?
- Citicoline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2023to 1 Apr 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Subjects who are unable or unwilling to give written informed consent or to comply with study protocol and who have no legal authorized representative available to give consent on their behalf
- Individuals being treated with extracorporeal membrane oxygenation (ECMO)
- Subjects who, in the clinicians estimation, will be unlikely to survive the protocol duration due to imminent and unavoidable risk of death
- Individuals with hypertonia of the parasympathetic nervous system
- Prisoners
- Children (<18 years)
Show all 11Show fewer
- Women who may be pregnant, are pregnant, or have plans to become pregnant
- Women who are breast feeding
- Individuals with a known allergy to citicoline
- Subjects that are taking medications that contain L-Dopa, centrophenoxine, or meclofenoxate
- Subjects with past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the principal investigator (PI), may pose additional risks from participation in the study or that may impact the quality or interpretation of the data obtained from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State Wexner Medical Center
Columbus, Ohio, 43210
About this study
The goal of this single center, double-blinded, placebo-controlled, and randomized Phase 1 trial is to determine if i.v. citicoline is safe and efficacious compared to i.v. saline/control in adults presenting with SARS CoV-2 infection complicated by acute hypoxemic respiratory failure. The main questions it aims to answer:
- Is citicoline safe in this patient population?
- Does citicoline have a benefit in terms of improving oxygenation?
- Does citicoline reduce overall severity of illness as reflected by standardized scales.
Patients will be assigned to i.v. treatment with citicoline or saline twice daily for 5 consecutive days. SpO2/FiO2 ratios will be recorded daily as per standard clinical practice to compare citicoline treatments at three different doses to placebo.
Read the detailed description
SCARLET is a single center, double-blinded, placebo-controlled, and randomized Phase 1 trial of i.v. citicoline in adult patients of any sex, gender, age, or ethnicity who are present with acute hypoxemic respiratory failure due to SARS CoV-2 infection. The goals are safety over a range of doses based on the number of treatment related adverse events as assessed by CTCAE v.5, and demonstration of efficacy as reflected by SpO2/FiO2 measured at day 3 in hospitalized COVID infected patients with acute hypoxemic respiratory failure, as defined by requiring at least 4 liters nasal cannula oxygen supplementation to maintain the SpO2 above 90%. The trial will enroll 20 patients per dose for 3 citicoline doses (1, 5, and 10 mg/kg/day) along with 20 placebo-treated controls.
- Conditions
- COVID-19
- Being tested
- Citicoline, Saline/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.
CiticolineDrug
Also called Somazina, CDP-choline
i.v. bolus administration every 12 hours for 5 days.
Saline/PlaceboDrug
Also called Normal saline solution
i.v. administered every 12 hours as a 10 ml bolus for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| IV 1 mg/kg/day Citicoline | Experimental | i.v. bolus of 10 ml normal saline containing citicoline 1 mg/kg, administered twice daily for 5 days. Receives: Drug: Citicoline |
| IV 5 mg/kg/day Citicoline | Experimental | i.v. bolus of 10 ml normal saline containing 5 mg/kg citicoline, administered twice daily for 5 days. Receives: Drug: Citicoline |
| IV 10 mg/kg/day Citicoline | Experimental | i.v. bolus of 10 ml normal saline containing 10 mg/kg citicoline, administered twice daily for 5 days. Receives: Drug: Citicoline |
| IV 10 ml normal saline | Placebo comparator | i.v. bolus of 10 ml normal saline (without active ingredient) administered i.v., twice daily for 5 days. Receives: Drug: Saline/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of citicoline over a range of doses in COVID-19 patients presenting with acute hypoxemic respiratory failure.
Safety will be assessed in each arm of the study: 1, 5, or 10 mg/kg/day citicoline by i.v. bolus or i.v. saline bolus for 5 consecutive days. Safety analysis will be performed based on a continuous safety monitoring rule to guide accrual suspension decisions based on number of treatment-related adverse events as assessed by the CTCAE v.5.0. The number of patients with an SAE that would warrant temporary suspension of accrual in a given group corresponds to a high posterior probability that the true SAE probability is greater than an acceptable level (i.e., Pr(pi > 0.25 | data) > 0.85), where the posterior probability is determined from a Beta-Binomial distribution with Beta (1, 1) as the prior on pi.
Measured: Until hospital discharge or up to 29 days
Citicoline's effect on acute hypoxemic respiratory failure in COVID-19 patients.
The primary clinical outcome will be measured on Day 3: lowest recorded SpO2/FiO2 ratio.
Measured: Day 3
Secondary outcomes (2)
Effect of citicoline on COVID specific disease severity scale in patients with acute COVID associated hypoxemic respiratory failure.
Days 1,3,5 and 8 COVID ordinal outcomes scale (COOS). The COOS scale ranges from 0-8 with higher scores corresponding with worse clinical outcomes.
Measured: Through day 8
Effect of citicoline on Sequential Organ Failure Score (SOFA) in patients with COVID associated acute respiratory failure.
Days 1,3,5, and 8 composite and component SOFA scores measure while the study subject is in the ICU. SOFA scores range from 0-24 with higher scores corresponding to more severe organ failures.
Measured: Through day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start6 Jun 2023
- Primary completion17 Mar 2025
- Study completion1 Apr 2026 (estimated)
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.
- More trials run by Ohio State UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elliott Crouser, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881135
- Sponsor's protocol ID
- 2022H0451
- Acronym
- SCARLET
- Status last verified
- Mar 2025
- First submitted
- 25 Apr 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pannu S, Exline MC, Bednash JS, Englert JA, Diaz P, Bartlett A, Brock G, Wu Q, Davis IC, Crouser ED. SCARLET (Supplemental Citicoline Administration to Reduce Lung injury Efficacy Trial): study protocol for a single-site, double-blinded, placebo-controlled, and randomized Phase 1/2 trial of i.v. citicoline (CDP-choline) in hospitalized SARS CoV-2-infected patients with hypoxemic acute respiratory failure. Trials. 2024 May 18;25(1):328. doi: 10.1186/s13063-024-08155-0.
PubMed 38760804
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET)
- ClinicalTrials.gov ID
- NCT05881135
- Acronym / sponsor ID
- SCARLET / 2022H0451
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 31 May 2023 (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 goal of this single center, double-blinded, placebo-controlled, and randomized Phase 1 trial is to determine if i.v. citicoline is safe and efficacious compared to i.v. saline/control in adults presenting with SARS CoV-2 infection complicated by acute hypoxemic respiratory failure. The main questions it aims to answer:
- Is citicoline safe in this patient population?
- Does citicoline have a benefit in terms of improving oxygenation?
- Does citicoline reduce overall severity of illness as reflected by standardized scales.
Patients will be assigned to i.v. treatment with citicoline or saline twice daily for 5 consecutive days. SpO2/FiO2 ratios will be recorded daily as per standard clinical practice to compare citicoline treatments at three different doses to placebo.
Detailed description
SCARLET is a single center, double-blinded, placebo-controlled, and randomized Phase 1 trial of i.v. citicoline in adult patients of any sex, gender, age, or ethnicity who are present with acute hypoxemic respiratory failure due to SARS CoV-2 infection. The goals are safety over a range of doses based on the number of treatment related adverse events as assessed by CTCAE v.5, and demonstration of efficacy as reflected by SpO2/FiO2 measured at day 3 in hospitalized COVID infected patients with acute hypoxemic respiratory failure, as defined by requiring at least 4 liters nasal cannula oxygen supplementation to maintain the SpO2 above 90%. The trial will enroll 20 patients per dose for 3 citicoline doses (1, 5, and 10 mg/kg/day) along with 20 placebo-treated controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IV 1 mg/kg/day Citicoline | Experimental | Drug: Citicolinei.v. bolus of 10 ml normal saline containing citicoline 1 mg/kg, administered twice daily for 5 days. |
| IV 5 mg/kg/day Citicoline | Experimental | Drug: Citicolinei.v. bolus of 10 ml normal saline containing 5 mg/kg citicoline, administered twice daily for 5 days. |
| IV 10 mg/kg/day Citicoline | Experimental | Drug: Citicolinei.v. bolus of 10 ml normal saline containing 10 mg/kg citicoline, administered twice daily for 5 days. |
| IV 10 ml normal saline | Placebo comparator | Drug: Saline/Placeboi.v. bolus of 10 ml normal saline (without active ingredient) administered i.v., twice daily for 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Subjects who are unable or unwilling to give written informed consent or to comply with study protocol and who have no legal authorized representative available to give consent on their behalf
- Individuals being treated with extracorporeal membrane oxygenation (ECMO)
- Subjects who, in the clinicians estimation, will be unlikely to survive the protocol duration due to imminent and unavoidable risk of death
- Individuals with hypertonia of the parasympathetic nervous system
- Prisoners
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 |
|---|---|---|
| CiticolineAlso: Somazina, CDP-cholinei.v. bolus administration every 12 hours for 5 days. | Drug | IV 1 mg/kg/day Citicoline, IV 10 mg/kg/day Citicoline, IV 5 mg/kg/day Citicoline |
| Saline/PlaceboAlso: Normal saline solutioni.v. administered every 12 hours as a 10 ml bolus for 5 days. | Drug | IV 10 ml normal saline |
Primary outcome
Safety of citicoline over a range of doses in COVID-19 patients presenting with acute hypoxemic respiratory failure.
Time frame: Until hospital discharge or up to 29 days
Safety will be assessed in each arm of the study: 1, 5, or 10 mg/kg/day citicoline by i.v. bolus or i.v. saline bolus for 5 consecutive days. Safety analysis will be performed based on a continuous safety monitoring rule to guide accrual suspension decisions based on number of treatment-related adverse events as assessed by the CTCAE v.5.0. The number of patients with an SAE that would warrant temporary suspension of accrual in a given group corresponds to a high posterior probability that the true SAE probability is greater than an acceptable level (i.e., Pr(pi > 0.25 | data) > 0.85), where the posterior probability is determined from a Beta-Binomial distribution with Beta (1, 1) as the prior on pi.
Citicoline's effect on acute hypoxemic respiratory failure in COVID-19 patients.
Time frame: Day 3
The primary clinical outcome will be measured on Day 3: lowest recorded SpO2/FiO2 ratio.
2 secondary outcomes
Effect of citicoline on COVID specific disease severity scale in patients with acute COVID associated hypoxemic respiratory failure.
Time frame: Through day 8
Effect of citicoline on Sequential Organ Failure Score (SOFA) in patients with COVID associated acute respiratory failure.
Time frame: Through day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 38760804Pannu S, Exline MC, Bednash JS, Englert JA, Diaz P, Bartlett A, Brock G, Wu Q, Davis IC, Crouser ED. SCARLET (Supplemental Citicoline Administration to Reduce Lung injury Efficacy Trial): study protocol for a single-site, double-blinded, placebo-controlled, and randomized Phase 1/2 trial of i.v. citicoline (CDP-choline) in hospitalized SARS CoV-2-infected patients with hypoxemic acute respiratory failure. Trials. 2024 May 18;25(1):328. doi: 10.1186/s13063-024-08155-0.
- Individual participant dataSharing planned: No
Related trials for COVID-19
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
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Citicoline in people with COVID-19, run by Ohio State University 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 0 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. 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. 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 combined 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.
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?
This study is still under way. Results are not available in the source record yet.
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?
Safety of citicoline over a range of doses in COVID-19 patients presenting with acute hypoxemic respiratory failure. (time frame: Until hospital discharge or up to 29 days). 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 NCT05881135, 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 2 Apr 2025.