NCT04307693

Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)

Terminated Phase 2 Last updated 27 May 2020

What this trial tests

Phase 2 trial testing Lopinavir/ritonavir in COVID-19 in 65 participants. Terminated before completion.

Timeline

11 March 2020

Primary endpoint
30 April 2020

30 April 2020

Quick facts

Lead sponsor	Asan Medical Center
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	65
Start date	11 March 2020
Primary completion	30 April 2020
Estimated completion	30 April 2020
Sites	1 location across South Korea

Drugs / interventions tested

• Lopinavir/ritonavir
• Hydroxychloroquine sulfate (hydroxychloroquine-pill) — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Asan Medical Center

Who can join

Adults 16 to 99, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the COVID-19 Pandemic.
   Driggin E, Madhavan MV, Bikdeli B, Chuich T, et al · · 2020 · cited 1272× · PMID 32201335 · DOI 10.1016/j.jacc.2020.03.031
2. The epidemiology, diagnosis and treatment of COVID-19.
   Zhai P, Ding Y, Wu X, Long J, et al · · 2020 · cited 461× · PMID 32234468 · DOI 10.1016/j.ijantimicag.2020.105955
3. COVID-19: Transmission, prevention, and potential therapeutic opportunities.
   Lotfi M, Hamblin MR, Rezaei N. · · 2020 · cited 447× · PMID 32474009 · DOI 10.1016/j.cca.2020.05.044
4. A Comprehensive Literature Review on the Clinical Presentation, and Management of the Pandemic Coronavirus Disease 2019 (COVID-19).
   Kakodkar P, Kaka N, Baig MN. · · 2020 · cited 255× · PMID 32269893 · DOI 10.7759/cureus.7560
5. Chloroquine and hydroxychloroquine in the treatment of COVID-19 with or without diabetes: A systematic search and a narrative review with a special reference to India and other developing countries.
   Singh AK, Singh A, Shaikh A, Singh R, et al · · 2020 · cited 250× · PMID 32247211 · DOI 10.1016/j.dsx.2020.03.011
6. Ongoing Clinical Trials for the Management of the COVID-19 Pandemic.
   Lythgoe MP, Middleton P. · · 2020 · cited 247× · PMID 32291112 · DOI 10.1016/j.tips.2020.03.006
7. Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
   Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
8. In vitro testing of combined hydroxychloroquine and azithromycin on SARS-CoV-2 shows synergistic effect.
   Andreani J, Le Bideau M, Duflot I, Jardot P, et al · · 2020 · cited 209× · PMID 32344177 · DOI 10.1016/j.micpath.2020.104228