Post-Acute COVID-19Phase 1/2CCTLongCOVIDNCT05582603
Safety and Dosage of a Computerized Cognitive Training Program for Cognitive Dysfunction After COVID-19
A Phase 1/2 study testing CCT Long COVID in people with Post-Acute COVID-19 and Post Acute COVID-19 Syndrome, run by Universidad Antonio de Nebrija at 1 site in Spain.
Trial summary
The goal of this Phase I/II clinical trial is to assess the safety and maximum tolerated training time of a self-administered computerized cognitive training (CCT) in individuals with cognitive dysfunction as a consequence of COVID-19 infection. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Acute COVID-19, Post Acute COVID-19 Syndrome, Cognitive Dysfunction
- What is being tested?
- CCT Long COVID
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 18 Oct 2022to 30 Nov 2022
- Phase
- Phase 1/2
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults between 25 and 55 years old.
- History of infection with COVID-19 at least 3 months prior to expression of interest with a valid diagnostic or antibody test.
- Presence of self-perceived cognitive dysfunction associated with post-acute sequelae of COVID-19 (concentration problems or brain fog).
Who cannot join
- Suicidal traits.
- Poor digital skills.
- Not having access to a mobile phone or tablet with Internet connection during the time of the intervention (only for Phase II).
- Not having 60 spare minutes per day to complete the intervention (only for Phase II).
Trial locations and contacts
1 site in 1 country.
David Asensio contact
About this study
Official title: Detailed Study on the Safety, Dosage and Feasibility of an Intervention Based on a Computerized Cognitive Training (CCT) for Individuals With Post-acute Sequelae of COVID-19 (PASC): A Phase I/II Trial
The goal of this Phase I/II clinical trial is to assess the safety and maximum tolerated training time of a self-administered computerized cognitive training (CCT) in individuals with cognitive dysfunction as a consequence of COVID-19 infection.
Read the detailed description
A Phase I/II protocol is designed to determine the safety of a Computerized Cognitive Training (CCT) aimed at ameliorating the cognitive dysfunction often observed in persons with post-acute sequelae of COVID-19 (PASC). The Phase I/II trial also aims at establishing the maximum tolerated training time per session of the CCT and to explore the feasibility of such intervention. In Phase I, through a 3+3 design, a dose-escalation trial will be set. Participants will be tested across subsequent training blocks of 15 minutes each, reporting on the experienced fatigue or adverse effects after every block. The safe training dose will be set to a block before extreme fatigue or a notable adverse effect has been reported by two or more participants. Once a safety training time has been established, a group of participants will engage in a 15-day training effectiveness assessment. After an initial thorough pre-test assessment, the intervention protocol will start. An evaluation day and a training day will be interspersed so that participants will complete a total of 8 training sessions (days 1, 3, 5, 7, 9, 11, 13 and 15). After the final day of intervention, a post-test assessment session will be carried out.
- Conditions
- Post-Acute COVID-19, Post Acute COVID-19 Syndrome, Cognitive Dysfunction, Cognitive Impairment
- Being tested
- CCT Long COVID
- Keywords
- post-acute sequelae of COVID-19, PASC, cognitive dysfunction, computerized cognitive training, brain training
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCT Long COVIDBehavioural
Also called CogniFit CCT Long COVID
A 15-day training protocol in which every 48 hours participants' complete a series of different cognitive tasks in the form of games selected among a pool of 12 games from CogniFit (CogniFit Inc., San Francisco, USA) whose difficulty level is tailored to each individual by the a patented Individualized Training System™ (ITS) software that automatically chooses the activities and difficulty levels for each person in every session.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Cognitive Training | Experimental | Individuals enrolled in Phase I and II will complete a Computerized Cognitive Training (CCT) based on an intervention with 15 different cognitive tasks in the form of games aimed at enhancing memory, attention, reasoning, perception and coordination skills. The CCT will be implemented in an app designed by CogniFit (CogniFit Inc., San Francisco, USA) to be used in tablets or mobile phones. Receives: Behavioral: CCT Long COVID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Level Questionnaire
Fatigue questionnaire adapted from the Brief Fatigue Inventory (Mendoza et al., 1999)
Measured: In Phase I, after each iteration of a 15-minute training.
Fatigue Level Questionnaire
Fatigue questionnaire adapted from the Brief Fatigue Inventory (Mendoza et al., 1999)
Measured: In Phase II, on even days (rest days of the intervention protocol).
Safety Level Questionnaire
Safety questionnaire aimed at exploring the existence of side effects and/or adverse events.
Measured: In Phase I, after each iteration of a 15-minute training.
Safety Level Questionnaire
Safety questionnaire aimed at exploring the existence of side effects and/or adverse events.
Measured: In Phase II, on even days (rest days of the intervention protocol).
Classification of side effect or adverse events
Interview adapted from the Patient-Reported Adverse Drug Event Questionnaire (de Vries et al., 2013).
Measured: In Phase I, after each iteration of a 15-minute training, only in case side effects or adverse events have been reported in the Safety Questionnaire.
Classification of side effect or adverse events
Interview adapted from the Patient-Reported Adverse Drug Event Questionnaire (de Vries et al., 2013).
Measured: In Phase II, on even days (rest days of the intervention protocol), only in case side effects or adverse events have been reported in the Safety Questionnaire.
Secondary outcomes (3)
Computerized Cognitive Assessment
Complete cognitive evaluation based on Cognitive Assessment Battery (CogniFit Inc., San Francisco, USA).
Measured: In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
Quality of Life Assessment
Short version of the self-perceived global physical and mental health scale from the Patient-Reported Outcomes Measurement Information System (PROMIS v.1.2).
Measured: In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
Paper-and-pencil Cognitive Assessment
The Montreal Cognitive Assessment (MoCA).
Measured: In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start18 Oct 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Acute 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I: An open-label prospective Phase I dose-escalation study following a standard 3+3 rule-based up-and-down design without dose de-escalation will be followed. Phase II: An open-label prospective clinical trial to validate the minimum dosage and appropriate safety using the training time obtained in Phase I for the CCT along a 15-day training period with a 24-hour rest between sessions.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Antonio de Nebrija
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Andoni Duñabeitia, Universidad Antonio de Nebrija
- Investigators
- Jon Andoni Duñabeitia, PhD, Principal investigator, Universidad Nebrija
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582603
- Sponsor's protocol ID
- UNNE-2021-010
- Acronym
- CCTLongCOVID
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detailed Study on the Safety, Dosage and Feasibility of an Intervention Based on a Computerized Cognitive Training (CCT) for Individuals With Post-acute Sequelae of COVID-19 (PASC): A Phase I/II Trial
- ClinicalTrials.gov ID
- NCT05582603
- Acronym / sponsor ID
- CCTLongCOVID / UNNE-2021-010
- Conditions
- Post-Acute COVID-19, Post Acute COVID-19 Syndrome, Cognitive Dysfunction, Cognitive Impairment
- Keywords
- post-acute sequelae of COVID-19, PASC, cognitive dysfunction, computerized cognitive training, brain training
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidad Antonio de NebrijaUniversity, hospital or other
- Study start
- 18 Oct 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 17 Oct 2022 (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 Phase I/II clinical trial is to assess the safety and maximum tolerated training time of a self-administered computerized cognitive training (CCT) in individuals with cognitive dysfunction as a consequence of COVID-19 infection.
Detailed description
A Phase I/II protocol is designed to determine the safety of a Computerized Cognitive Training (CCT) aimed at ameliorating the cognitive dysfunction often observed in persons with post-acute sequelae of COVID-19 (PASC). The Phase I/II trial also aims at establishing the maximum tolerated training time per session of the CCT and to explore the feasibility of such intervention. In Phase I, through a 3+3 design, a dose-escalation trial will be set. Participants will be tested across subsequent training blocks of 15 minutes each, reporting on the experienced fatigue or adverse effects after every block. The safe training dose will be set to a block before extreme fatigue or a notable adverse effect has been reported by two or more participants. Once a safety training time has been established, a group of participants will engage in a 15-day training effectiveness assessment. After an initial thorough pre-test assessment, the intervention protocol will start. An evaluation day and a training day will be interspersed so that participants will complete a total of 8 training sessions (days 1, 3, 5, 7, 9, 11, 13 and 15). After the final day of intervention, a post-test assessment session will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I: An open-label prospective Phase I dose-escalation study following a standard 3+3 rule-based up-and-down design without dose de-escalation will be followed. Phase II: An open-label prospective clinical trial to validate the minimum dosage and appropriate safety using the training time obtained in Phase I for the CCT along a 15-day training period with a 24-hour rest between sessions.
| Arm | Type | Receives |
|---|---|---|
| Computerized Cognitive Training | Experimental | Behavioral: CCT Long COVIDIndividuals enrolled in Phase I and II will complete a Computerized Cognitive Training (CCT) based on an intervention with 15 different cognitive tasks in the form of games aimed at enhancing memory, attention, reasoning, perception and coordination skills. The CCT will be implemented in an app designed by CogniFit (CogniFit Inc., San Francisco, USA) to be used in tablets or mobile phones. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults between 25 and 55 years old.
- History of infection with COVID-19 at least 3 months prior to expression of interest with a valid diagnostic or antibody test.
- Presence of self-perceived cognitive dysfunction associated with post-acute sequelae of COVID-19 (concentration problems or brain fog).
Key exclusion criteria (4 listed)
- Suicidal traits.
- Poor digital skills.
- Not having access to a mobile phone or tablet with Internet connection during the time of the intervention (only for Phase II).
- Not having 60 spare minutes per day to complete the intervention (only for Phase II).
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 |
|---|---|---|
| CCT Long COVIDAlso: CogniFit CCT Long COVIDA 15-day training protocol in which every 48 hours participants' complete a series of different cognitive tasks in the form of games selected among a pool of 12 games from CogniFit (CogniFit Inc., San Francisco, USA) whose difficulty level is tailored to each individual by the a patented Individualized Training System™ (ITS) software that automatically chooses the activities and difficulty levels for each person in every session. | Behavioural | Computerized Cognitive Training |
Primary outcome
Fatigue Level Questionnaire
Time frame: In Phase I, after each iteration of a 15-minute training.
Fatigue questionnaire adapted from the Brief Fatigue Inventory (Mendoza et al., 1999)
Fatigue Level Questionnaire
Time frame: In Phase II, on even days (rest days of the intervention protocol).
Fatigue questionnaire adapted from the Brief Fatigue Inventory (Mendoza et al., 1999)
Safety Level Questionnaire
Time frame: In Phase I, after each iteration of a 15-minute training.
Safety questionnaire aimed at exploring the existence of side effects and/or adverse events.
Safety Level Questionnaire
Time frame: In Phase II, on even days (rest days of the intervention protocol).
Safety questionnaire aimed at exploring the existence of side effects and/or adverse events.
Classification of side effect or adverse events
Time frame: In Phase I, after each iteration of a 15-minute training, only in case side effects or adverse events have been reported in the Safety Questionnaire.
Interview adapted from the Patient-Reported Adverse Drug Event Questionnaire (de Vries et al., 2013).
Classification of side effect or adverse events
Time frame: In Phase II, on even days (rest days of the intervention protocol), only in case side effects or adverse events have been reported in the Safety Questionnaire.
Interview adapted from the Patient-Reported Adverse Drug Event Questionnaire (de Vries et al., 2013).
3 secondary outcomes
Computerized Cognitive Assessment
Time frame: In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
Quality of Life Assessment
Time frame: In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
Paper-and-pencil Cognitive Assessment
Time frame: In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: No
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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.
David Asensio contact
Jon Andoni Duñabeitia, PhD principal investigator
Universidad Nebrija
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 CCT Long COVID in people with Post-Acute COVID-19 and Post Acute COVID-19 Syndrome, run by Universidad Antonio de Nebrija at 1 site in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 18 Oct 2022. 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 Spain. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jon Andoni Duñabeitia, PhD (0034 900321322, jdunabeitia@nebrija.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Level Questionnaire (time frame: In Phase I, after each iteration of a 15-minute training.). 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 18 Oct 2022.