NCT04387240

Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19

Withdrawn Phase 2 Last updated 26 April 2022

What this trial tests

Phase 2 trial testing Artemisinin / Artesunate in Covid 19 Positive. Withdrawn.

Timeline

1 January 2022

Primary endpoint
1 September 2022

1 December 2022

Quick facts

Lead sponsor	Princess Nourah Bint Abdulrahman University
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Start date	1 January 2022
Primary completion	1 September 2022
Estimated completion	1 December 2022
Sites	1 location across Saudi Arabia

Drugs / interventions tested

• Artemisinin / Artesunate — full drug profile →
• placebo

Conditions studied

• Covid 19 Positive — all drugs for Covid 19 Positive →
• Corona Virus Infection — all drugs for Corona Virus Infection →

Sponsor

Princess Nourah Bint Abdulrahman University

Who can join

Adults 18 to 60, any sex, with Covid 19 Positive or Corona Virus Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• length of stay in hospital
  Time frame: within the first 6 days intervention
  absence of the virus shedding evidenced by negative swabs

Sponsor's own description

Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus.

At this time, there are no specific vaccines or treatments for COVID-19. However, there are many ongoing clinical trials evaluating potential treatments Drugs used to treat malaria infection has shown to be beneficial for many other diseases, including viral infections.

In this Clinical trial, Investigators will evaluate the effect of Artemisinin / Artesunate on morbidity of COVID-19 patients in decreasing the course of the disease and viral load in symptomatic stable positive swab COVID-19 patients. Investigators are hypothesizing that due to the antiviral properties of this drug it will help as a treatment for the COVID -19 patients. In improving their condition and clearing the virus load,

Publications & conference data

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

1. 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
2. Activation of GPR37 in macrophages confers protection against infection-induced sepsis and pain-like behaviour in mice.
   Bang S, Donnelly CR, Luo X, Toro-Moreno M, et al · · 2021 · cited 72× · PMID 33731716 · DOI 10.1038/s41467-021-21940-8
3. Multi-omics-based identification of SARS-CoV-2 infection biology and candidate drugs against COVID-19.
   Barh D, Tiwari S, Weener ME, Azevedo V, et al · · 2020 · cited 57× · PMID 33131530 · DOI 10.1016/j.compbiomed.2020.104051
4. <i>Artemisia</i> spp.: An Update on Its Chemical Composition, Pharmacological and Toxicological Profiles.
   Sharifi-Rad J, Herrera-Bravo J, Semwal P, Painuli S, et al · · 2022 · cited 36× · PMID 36105486 · DOI 10.1155/2022/5628601
5. Pharmacological Modulators of Autophagy as a Potential Strategy for the Treatment of COVID-19.
   Pereira GJDS, Leão AHFF, Erustes AG, Morais IBM, et al · · 2021 · cited 36× · PMID 33920748 · DOI 10.3390/ijms22084067
6. Potential Anti-SARS-CoV-2 Therapeutics That Target the Post-Entry Stages of the Viral Life Cycle: A Comprehensive Review.
   Al-Horani RA, Kar S. · · 2020 · cited 33× · PMID 32993173 · DOI 10.3390/v12101092
7. <i>Artemisia</i> Spp. Derivatives for COVID-19 Treatment: Anecdotal Use, Political Hype, Treatment Potential, Challenges, and Road Map to Randomized Clinical Trials.
   Kapepula PM, Kabengele JK, Kingombe M, Van Bambeke F, et al · · 2020 · cited 30× · PMID 32705976 · DOI 10.4269/ajtmh.20-0820
8. Repurposing Anti-Malaria Phytomedicine Artemisinin as a COVID-19 Drug.
   Uckun FM, Saund S, Windlass H, Trieu V. · · 2021 · cited 29× · PMID 33815126 · DOI 10.3389/fphar.2021.649532