Post-acute Sequelae of COVID-19Phase 2NCT05690503
Glutamatergic Modulation as a Treatment for Depressive Symptoms Among Patients With Post-acute Sequelae of COVID (PASC): A Pilot Trial
A Phase 2 study testing CI-581a and CI-581b in people with Post-acute Sequelae of COVID-19 and Depressive Symptoms, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Post-acute sequelae of SARS-CoV2 (PASC), colloquially known as "long-COVID," is thought to affect between 10-30% of all COVID-19 survivors. Patients with PASC also report worsening behavioral health symptoms over time that include new-onset depression, anxiety, and even suicidal behavior. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-acute Sequelae of COVID-19, Depressive Symptoms, Cognitive Dysfunction
- What is being tested?
- CI-581a and CI-581b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2023to 31 Dec 2025
- Phase
- Phase 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting the case-definition for PASC with depressive symptoms
- Otherwise physically healthy
- No adverse reactions to study medications
- Capacity to consent and comply with study procedures, including sufficient proficiency in English
- Sexually active participants must use an effective form of birth control (condom plus spermicide, diaphragm plus spermicide, or birth control pills) before and throughout their study participation.
- Willingness to provide one or more emergency contacts to the study team
Who cannot join
- Meeting the DSM-5 criteria for lifetime history of bipolar disorder, schizophrenia, or any psychotic illness.
- Lifetime history of delirium, dementia, amnesia, or dissociative disorders
- Current suicide risk or a history of suicide attempt within the past year
- Pregnant or interested in becoming pregnant during the study period.
- Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia within 1 year of signing study consent form.
- Unstable physical disorders which might make participation hazardous such as hypertension (>160/90), anemia, active hepatitis or other liver disease (transaminase levels <3 X the upper limit of normal will be considered acceptable), epilepsy, or untreated diabetes. Participants reporting HIV+ status will be asked to provide information about their current treatment, including all medications. Participants who are on the antiretroviral ritonavir (Norvir) will be excluded due to the possibility that ketamine in combination with this medication may increase the risk of drug-induced hepatitis.
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- Previous history of a substance use disorder with the study medications, and/or a history of an adverse reaction/experience with prior exposure to the study medications.
- Recent history of significant violence (past 2 years) leading to an individual incurring physical harm, police involvement, or resulting in legal action.
- On psychotropic or other medications whose effect could be disrupted by participation in the study.
- Other personal circumstances and behavior judged to be incompatible with establishment of rapport or safe exposure to the study medications.
- Physiologic dependence on a substance including benzodiazepines, alcohol, or opioids.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Post-acute sequelae of SARS-CoV2 (PASC), colloquially known as "long-COVID," is thought to affect between 10-30% of all COVID-19 survivors. Patients with PASC also report worsening behavioral health symptoms over time that include new-onset depression, anxiety, and even suicidal behavior. The purpose of this randomized, double-blind, controlled trial is to test the efficacy of a glutamate modulator among PASC patients suffering from new-onset or worsening of depressive symptoms.
Read the detailed description
While PASC symptoms have been identified in nearly every organ system, the most common symptoms include fatigue, cognitive and attention deficits (known as 'brain fog'), shortness of breath, and post-exertional malaise. New-onset depression, anxiety, and even suicidal behavior have also been reported. Symptoms of PASC can exhibit daily variation; additionally PASC frequently demonstrates a relapsing and remitting course. This is mitigated by cognitive and emotional stress, physical exertion, diet, and alcohol consumption; therefore, measuring treatment response and the course of illness over time can be challenging. While there are many ongoing trials evaluating a variety of treatments for PASC, no clear treatment has emerged; additionally, there are no published data on psychotropic medications alleviating the inflammatory response and psychiatric symptoms in PASC.
Alterations in the transmission between neurons of a neurotransmitter called glutamate are an important target of pharmacotherapy for PASC. Glutamate modulators have demonstrated promise in improving depressive symptoms and suicidality and can improve cognitive functioning among patients with these symptoms. The study team has recently developed a novel design that integrates a clinical trial involving serial infusions. The current trial will evaluate the effect of a sub-anesthetic infusion on individuals with PASC and depressive symptoms who complete a randomized, double-blind, placebo-controlled pilot study conducted over 5 weeks using a cross-over and counterbalanced design.
- Being tested
- CI-581a, CI-581b
- Keywords
- Ketamine, PASC, Long Covid
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Depression, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CI-581aDrug
Medication infusion intravenously over 90 minutes.
CI-581bDrug
Medication infusion intravenously over 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| CI-581a+CI-581b | Experimental | Administration of CI-581a at 0.8mg/kg during week 1. Administration of CI-581b at 0.025mg/kg during week 3. Receives: Drug: CI-581a; Drug: CI-581b |
| CI-581b+CI-581a | Experimental | Administration of CI-581b at 0.025mg/kg during week 1. Administration of CI-581a at 0.8mg/kg during week 3. Receives: Drug: CI-581a; Drug: CI-581b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in depressive symptoms
Measured: from baseline to week 5.
Secondary outcomes (1)
Improvement in neurocognitive symptoms of PASC
Measured: from baseline to week 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start20 Mar 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-acute Sequelae of 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elias Dakwar, New York State Psychiatric Institute
- Investigators
- Saleena Subaiya, MD, Principal investigator, New York State Psychiatric InstituteElias Dakwar, MD, Principal investigator, New York State Psychiatric InstituteKate O'Malley, MA, Study director, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690503
- Sponsor's protocol ID
- 8336
- Status last verified
- Jul 2024
- First submitted
- 30 Dec 2022
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutamatergic Modulation as a Treatment for Depressive Symptoms Among Patients With Post-acute Sequelae of COVID (PASC): A Pilot Trial
- ClinicalTrials.gov ID
- NCT05690503
- Acronym / sponsor ID
- 8336
- Keywords
- Ketamine, PASC, Long Covid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Jan 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.
Post-acute sequelae of SARS-CoV2 (PASC), colloquially known as "long-COVID," is thought to affect between 10-30% of all COVID-19 survivors. Patients with PASC also report worsening behavioral health symptoms over time that include new-onset depression, anxiety, and even suicidal behavior. The purpose of this randomized, double-blind, controlled trial is to test the efficacy of a glutamate modulator among PASC patients suffering from new-onset or worsening of depressive symptoms.
Detailed description
While PASC symptoms have been identified in nearly every organ system, the most common symptoms include fatigue, cognitive and attention deficits (known as 'brain fog'), shortness of breath, and post-exertional malaise. New-onset depression, anxiety, and even suicidal behavior have also been reported. Symptoms of PASC can exhibit daily variation; additionally PASC frequently demonstrates a relapsing and remitting course. This is mitigated by cognitive and emotional stress, physical exertion, diet, and alcohol consumption; therefore, measuring treatment response and the course of illness over time can be challenging. While there are many ongoing trials evaluating a variety of treatments for PASC, no clear treatment has emerged; additionally, there are no published data on psychotropic medications alleviating the inflammatory response and psychiatric symptoms in PASC.
Alterations in the transmission between neurons of a neurotransmitter called glutamate are an important target of pharmacotherapy for PASC. Glutamate modulators have demonstrated promise in improving depressive symptoms and suicidality and can improve cognitive functioning among patients with these symptoms. The study team has recently developed a novel design that integrates a clinical trial involving serial infusions. The current trial will evaluate the effect of a sub-anesthetic infusion on individuals with PASC and depressive symptoms who complete a randomized, double-blind, placebo-controlled pilot study conducted over 5 weeks using a cross-over and counterbalanced design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CI-581a+CI-581b | Experimental | Drug: CI-581a, Drug: CI-581bAdministration of CI-581a at 0.8mg/kg during week 1. Administration of CI-581b at 0.025mg/kg during week 3. |
| CI-581b+CI-581a | Experimental | Drug: CI-581a, Drug: CI-581bAdministration of CI-581b at 0.025mg/kg during week 1. Administration of CI-581a at 0.8mg/kg during week 3. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meeting the case-definition for PASC with depressive symptoms
- Otherwise physically healthy
- No adverse reactions to study medications
- Capacity to consent and comply with study procedures, including sufficient proficiency in English
- Sexually active participants must use an effective form of birth control (condom plus spermicide, diaphragm plus spermicide, or birth control pills) before and throughout their study participation.
Key exclusion criteria (11 listed)
- Meeting the DSM-5 criteria for lifetime history of bipolar disorder, schizophrenia, or any psychotic illness.
- Lifetime history of delirium, dementia, amnesia, or dissociative disorders
- Current suicide risk or a history of suicide attempt within the past year
- Pregnant or interested in becoming pregnant during the study period.
- Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia within 1 year of signing study consent form.
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 |
|---|---|---|
| CI-581aMedication infusion intravenously over 90 minutes. | Drug | CI-581a+CI-581b, CI-581b+CI-581a |
| CI-581bMedication infusion intravenously over 90 minutes. | Drug | CI-581a+CI-581b, CI-581b+CI-581a |
Primary outcome
Reduction in depressive symptoms
Time frame: from baseline to week 5.
1 secondary outcome
Improvement in neurocognitive symptoms of PASC
Time frame: from baseline to week 5.
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 16 Jul 2024.
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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.
Saleena Subaiya, MD principal investigator
New York State Psychiatric Institute
Elias Dakwar, MD principal investigator
New York State Psychiatric Institute
Kate O'Malley, MA study director
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CI-581a and CI-581b in people with Post-acute Sequelae of COVID-19 and Depressive Symptoms, run by New York State Psychiatric Institute 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 6 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 16 Jul 2024. 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 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?
Reduction in depressive symptoms (time frame: from baseline to week 5.). 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 16 Jul 2024.