COVID-19SARS-CoV-2NCT06610643
Extended Remdesivir Infusion Combined With Nirmatrelvir/Ritonavir for Persistent SARS-CoV-2 Infection in Immunocompromised Patients
A study testing combination therapy and SOC in people with COVID-19 and SARS-CoV-2, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To evaluate the safety and efficacy of extended remdesivir infusion, targeting on immunocompromised individuals who had positive SARS-CoV-2 PCR despite an oral antiviral agent prescription. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2, Immunocompromised
- What is being tested?
- combination therapy and SOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Sep 2024to 31 Dec 2026
- Phase
- Interventional
- 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
- Age ≥ 18 years
- Receive B-cell depletion therapy or bendamustine within 6months
- Laboratory confirmed SARS-CoV-2 infection
- Symptoms onset within 72 hours
- NIAID ordinal score 0-5 upon enrollment
Who cannot join
- Prior use of any anti-SARS-CoV-2 agents within 2 weeks. Remdesivir or NMV/r initiated within 24 hours is acceptable
- Life expectancy \< 1 month
- Previous adverse effect related to remdesivir or NMV/r
- Concurrent use medicine with drug-drug interaction with NMV/r
- Patients receiving intubation and mechanical ventilation
- eGFR \< 30
- Child pugh score Class C
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100225
Fu-Chang Tsai, Professor, +886-2312-3456 ext. 288576, fctsai@ntu.edu.tw
About this study
To evaluate the safety and efficacy of extended remdesivir infusion, targeting on immunocompromised individuals who had positive SARS-CoV-2 PCR despite an oral antiviral agent prescription.
Read the detailed description
Prolonged viral shedding is commonly observed in immunocompromised patients infected by SARS-CoV-2. Until now, there is no successful clinical trial or guideline to guide optimal treatment for this clinical condition. Here, we aimed to establish a clinical trial with combination of prolonged remdesivir infusion with nirmatrelvir/ritonavir among COVID-19 patients recently receiving b-cell depletion therapy, to evaluate to clinical outcomes.
- Conditions
- COVID-19, SARS-CoV-2, Immunocompromised
- Being tested
- combination therapy, SOC
- Keywords
- Extended RDV infusion combination therapy for SARS-CoV-2 infection in immunocompromised patients
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination therapyDrug
Also called remdesivir and Nirmatrelvir/Ritonavir
A combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir
SOCDrug
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| combination therapy | Experimental | combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir Receives: Drug: combination therapy; Drug: SOC |
| SOC | Active comparator | standard of care Receives: Drug: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of SARS-CoV-2 CT > 30 on Day 14
The proportion of SARS-CoV-2 CT \> 30 on Day 14 of each group.
Measured: From enrollment to the end of treatment on Day 14.
Secondary outcomes (4)
The proportion of mortality or respiratory failure requiring intubation and mechanical ventilation.
The proportion of mortality or respiratory failure requiring intubation and mechanical ventilation within 28 days after antiviral agent initiation of each group.
Measured: From enrollment to the end of treatment on Day 28.
The proportion of patients developing anti-viral treatment emerging adverse events.
The proportion of patients developing anti-viral treatment emerging adverse events.
Measured: From enrollment to the end of treatment on Day 28.
The proportion of secondary bacterial or fungal infection of each group.
The proportion of secondary bacterial or fungal infection of each group.
Measured: From enrollment to the end of treatment on Day 28.
The proportion of viral rebound within 28 days after antiviral agent initiation.
The proportion of viral rebound within 28 days after antiviral agent initiation of each group.
Measured: From enrollment to the end of treatment on Day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start21 Sep 2024 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610643
- Sponsor's protocol ID
- 202405064MIND
- Acronym
- SARS-CoV-2
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Remdesivir Infusion Combined With Nirmatrelvir/Ritonavir for Persistent SARS-CoV-2 Infection in Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT06610643
- Acronym / sponsor ID
- SARS-CoV-2 / 202405064MIND
- Conditions
- COVID-19, SARS-CoV-2, Immunocompromised
- Keywords
- Extended RDV infusion combination therapy for SARS-CoV-2 infection in immunocompromised patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 21 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Sep 2024 (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.
To evaluate the safety and efficacy of extended remdesivir infusion, targeting on immunocompromised individuals who had positive SARS-CoV-2 PCR despite an oral antiviral agent prescription.
Detailed description
Prolonged viral shedding is commonly observed in immunocompromised patients infected by SARS-CoV-2. Until now, there is no successful clinical trial or guideline to guide optimal treatment for this clinical condition. Here, we aimed to establish a clinical trial with combination of prolonged remdesivir infusion with nirmatrelvir/ritonavir among COVID-19 patients recently receiving b-cell depletion therapy, to evaluate to clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination therapy | Experimental | Drug: combination therapy, Drug: SOCcombination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir |
| SOC | Active comparator | Drug: SOCstandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Receive B-cell depletion therapy or bendamustine within 6months
- Laboratory confirmed SARS-CoV-2 infection
- Symptoms onset within 72 hours
- NIAID ordinal score 0-5 upon enrollment
Key exclusion criteria (8 listed)
- Prior use of any anti-SARS-CoV-2 agents within 2 weeks. Remdesivir or NMV/r initiated within 24 hours is acceptable
- Life expectancy \< 1 month
- Previous adverse effect related to remdesivir or NMV/r
- Concurrent use medicine with drug-drug interaction with NMV/r
- Patients receiving intubation and mechanical ventilation
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 |
|---|---|---|
| combination therapyAlso: remdesivir and Nirmatrelvir/RitonavirA combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir | Drug | combination therapy |
| SOCStandard of care | Drug | SOC, combination therapy |
Primary outcome
The proportion of SARS-CoV-2 CT > 30 on Day 14
Time frame: From enrollment to the end of treatment on Day 14.
The proportion of SARS-CoV-2 CT \> 30 on Day 14 of each group.
4 secondary outcomes
The proportion of mortality or respiratory failure requiring intubation and mechanical ventilation.
Time frame: From enrollment to the end of treatment on Day 28.
The proportion of patients developing anti-viral treatment emerging adverse events.
Time frame: From enrollment to the end of treatment on Day 28.
The proportion of secondary bacterial or fungal infection of each group.
Time frame: From enrollment to the end of treatment on Day 28.
The proportion of viral rebound within 28 days after antiviral agent initiation.
Time frame: From enrollment to the end of treatment on Day 28.
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 25 Sep 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combination therapy and SOC in people with COVID-19 and SARS-CoV-2, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 25 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 1 site in Taiwan. 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?
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?
Contact Jann-Tay Wang, M. D., Ph.D. (+886-2-2312-3456 ext. 263517, wangjt1124@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of SARS-CoV-2 CT > 30 on Day 14 (time frame: From enrollment to the end of treatment on Day 14.). 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 25 Sep 2024.