COVID-19Phase 2NCT04307693
Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
A Phase 2 study testing Lopinavir/ritonavir and Hydroxychloroquine sulfate in people with COVID-19, run by Asan Medical Center at 1 site in South Korea.
Trial summary
In vitro studies revealed that lopinavir/ritonavir and hydroxychloroquine have antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, there is no clinical studies on the reduction of viral load in patients with COVID-19. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Lopinavir/ritonavir and Hydroxychloroquine sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Mar 2020to 30 Apr 2020
- Phase
- Phase 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 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- confirmed mild COVID-19 (NEWS scoring system 0-4)
Who cannot join
- unable to take oral medication
- pregnancy or breast feeding
- immunocompromised patients
- creatinine clearance (CCL) < 30 mL/min
- aspartate transaminase (AST) or alanine transaminase (ALT) > 5 times Upper limit of normal (ULN)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 138-736
About this study
Official title: Randomized Controlled Clinical Trials of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
In vitro studies revealed that lopinavir/ritonavir and hydroxychloroquine have antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, there is no clinical studies on the reduction of viral load in patients with COVID-19. This study investigate whether lopinavir/ritonavir or hydroxychloroquine reduces viral load from respiratory specimen in patients with mild COVID-19.
Read the detailed description
This multicenter study is an open-labelled, randomized clinical trial for 1:1:1 ratio of lopinavir/ritonavir, hydroxychloroquine, or control arm.
- Conditions
- COVID-19
- Being tested
- Lopinavir/ritonavir, Hydroxychloroquine sulfate
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir/ritonavirDrug
Also called Kaletra
Lopinavir / Ritonavir tablet
Hydroxychloroquine sulfateDrug
Also called Oxiklorin
Hydroxychloroquine sulfate tablet
| Study group | Role | What they receive |
|---|---|---|
| Lopinavir/ritonavir | Experimental | Lopinavir/ritonavir 200mg/100mg 2 tablets by mouth, every 12 hours for 7-10 days Receives: Drug: Lopinavir/ritonavir |
| Hydroxychloroquine | Active comparator | Hydroxychloroquine 400mg by mouth, every 24 hours for 7-10 days Receives: Drug: Hydroxychloroquine sulfate |
| Control | No intervention | No lopinavir/ritonavir and hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load
Area under the curve (AUC) of Ct value or viral copies number per mL
Measured: hospital day 3, 5, 7, 10, 14, 18
Secondary outcomes (8)
Viral load change
Viral load change (log10 viral load assessed by reverse transcription-PCR) during hospital day 3, 5, 7, 10, 14, 18)
Measured: hospital day 3, 5, 7, 10, 14, 18
Time to clinical improvement (TTCI)
Time to clinical improvement (TTCI) is defined as the time to normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough within at least 72 hours
Measured: up to 28 days
Percentage of progression to supplemental oxygen requirement by day 7
Percentage of progression to supplemental oxygen requirement by day 7
Measured: hospital day 7
Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7
Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7
Measured: hospital day 7
Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission
Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission
Measured: up to 28 days
Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
Measured: hospital day 7
adverse effects
Safety and tolerability, as assessed by adverse effects
Measured: up to 28 days
Concentration of Lopinavir/ritonavir and hydroxychloroquine
Concentration of Lopinavir/ritonavir and hydroxychloroquine
Measured: 1, 2, 4, 5, 12 hours after taking intervention medicine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start11 Mar 2020
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Why it stopped: Terminated early because no patients were further enrolled since mid-Apr 2020.
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 Asan Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, open labelled, randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Han Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307693
- Sponsor's protocol ID
- S2020-0472-0001
- Status last verified
- May 2020
- First submitted
- 10 Mar 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lipsitch M, Perlman S, Waldor MK. Testing COVID-19 therapies to prevent progression of mild disease. Lancet Infect Dis. 2020 Dec;20(12):1367. doi: 10.1016/S1473-3099(20)30372-8. Epub 2020 May 6. No abstract available.
PubMed 32618282
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trials of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
- ClinicalTrials.gov ID
- NCT04307693
- Acronym / sponsor ID
- S2020-0472-0001
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early because no patients were further enrolled since mid-Apr 2020.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 13 Mar 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.
In vitro studies revealed that lopinavir/ritonavir and hydroxychloroquine have antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, there is no clinical studies on the reduction of viral load in patients with COVID-19. This study investigate whether lopinavir/ritonavir or hydroxychloroquine reduces viral load from respiratory specimen in patients with mild COVID-19.
Detailed description
This multicenter study is an open-labelled, randomized clinical trial for 1:1:1 ratio of lopinavir/ritonavir, hydroxychloroquine, or control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Multicenter, open labelled, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Lopinavir/ritonavir | Experimental | Drug: Lopinavir/ritonavirLopinavir/ritonavir 200mg/100mg 2 tablets by mouth, every 12 hours for 7-10 days |
| Hydroxychloroquine | Active comparator | Drug: Hydroxychloroquine sulfateHydroxychloroquine 400mg by mouth, every 24 hours for 7-10 days |
| Control | No intervention | –No lopinavir/ritonavir and hydroxychloroquine |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- confirmed mild COVID-19 (NEWS scoring system 0-4)
Key exclusion criteria (5 listed)
- unable to take oral medication
- pregnancy or breast feeding
- immunocompromised patients
- creatinine clearance (CCL) < 30 mL/min
- aspartate transaminase (AST) or alanine transaminase (ALT) > 5 times Upper limit of normal (ULN)
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 |
|---|---|---|
| Lopinavir/ritonavirAlso: KaletraLopinavir / Ritonavir tablet | Drug | Lopinavir/ritonavir |
| Hydroxychloroquine sulfateAlso: OxiklorinHydroxychloroquine sulfate tablet | Drug | Hydroxychloroquine |
Primary outcome
Viral load
Time frame: hospital day 3, 5, 7, 10, 14, 18
Area under the curve (AUC) of Ct value or viral copies number per mL
8 secondary outcomes
Viral load change
Time frame: hospital day 3, 5, 7, 10, 14, 18
Time to clinical improvement (TTCI)
Time frame: up to 28 days
Percentage of progression to supplemental oxygen requirement by day 7
Time frame: hospital day 7
Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7
Time frame: hospital day 7
Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission
Time frame: up to 28 days
Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
Time frame: hospital day 7
adverse effects
Time frame: up to 28 days
Concentration of Lopinavir/ritonavir and hydroxychloroquine
Time frame: 1, 2, 4, 5, 12 hours after taking intervention medicine
Results and safety
The study was stopped early (reason given: Terminated early because no patients were further enrolled since mid-Apr 2020.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Derived from this study: PubMed 32618282Lipsitch M, Perlman S, Waldor MK. Testing COVID-19 therapies to prevent progression of mild disease. Lancet Infect Dis. 2020 Dec;20(12):1367. doi: 10.1016/S1473-3099(20)30372-8. Epub 2020 May 6. No abstract available.
- 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.
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 2 study testing Lopinavir/ritonavir and Hydroxychloroquine sulfate in people with COVID-19, run by Asan Medical Center at 1 site in South Korea.
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 5 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: stopped early, as of the sponsor's last update on 27 May 2020. 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 South Korea. 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?
The study was stopped early (reason given: Terminated early because no patients were further enrolled since mid-Apr 2020.). Results are not available in the source record.
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?
Viral load (time frame: hospital day 3, 5, 7, 10, 14, 18). 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 NCT04307693, 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 27 May 2020.