NCT04322344: add-on-COV2

Escin in Patients With Covid-19 Infection

Status unknown Phase 2, PHASE3 Last updated 16 September 2020

What this trial tests

Phase 2, PHASE3 trial testing Escin in Coronavirus Infections in 120 participants. Status unknown.

Timeline

23 March 2020

Primary endpoint
30 June 2020

30 December 2020

Quick facts

Lead sponsor	University of Catanzaro
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	120
Start date	23 March 2020
Primary completion	30 June 2020
Estimated completion	30 December 2020
Sites	1 location across Italy

Drugs / interventions tested

• Escin (ESCIN) — full drug profile →
• standard therapy — full drug profile →

Conditions studied

• Coronavirus Infections — all drugs for Coronavirus Infections →

Sponsor

University of Catanzaro

Who can join

Adults 18 to 75, any sex, with Coronavirus Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In December 2019,a new type of pneumonia caused by the coronavirus (COVID-2019) broke out in Wuhan ,China, and spreads quickly to other Chinese cities and 28 countries. More than 70000 people were infected and over 2000 people died all over the world. There is no specific drug treatment for this disease. Considering that lung damage is related to both viral infection and burst of cytokines, our idea is to evaluate the efficacy and safety of escin as add-on treatment to conventional antiviral drugs in COVID-19 infected patients.

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. Severe Acute Lung Injury Related to COVID-19 Infection: A Review and the Possible Role for Escin.
   Gallelli L, Zhang L, Wang T, Fu F, et al · · 2020 · cited 76× · PMID 32441805 · DOI 10.1002/jcph.1644
3. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
   Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
4. Traditional Herbal Medicines, Bioactive Metabolites, and Plant Products Against COVID-19: Update on Clinical Trials and Mechanism of Actions.
   Alam S, Sarker MMR, Afrin S, Richi FT, et al · · 2021 · cited 61× · PMID 34122096 · DOI 10.3389/fphar.2021.671498
5. Review of registered clinical trials for the treatment of COVID-19.
   Babaei F, Mirzababaei M, Nassiri-Asl M, Hosseinzadeh H. · · 2021 · cited 31× · PMID 33251593 · DOI 10.1002/ddr.21762
6. Revisiting potential druggable targets against SARS-CoV-2 and repurposing therapeutics under preclinical study and clinical trials: A comprehensive review.
   Sohag AAM, Hannan MA, Rahman S, Hossain M, et al · · 2020 · cited 26× · PMID 32632960 · DOI 10.1002/ddr.21709
7. Primed for global coronavirus pandemic: Emerging research and clinical outcome.
   Ahamad S, Branch S, Harrelson S, Hussain MK, et al · · 2021 · cited 25× · PMID 33070079 · DOI 10.1016/j.ejmech.2020.112862
8. <i>In silico</i> investigation and potential therapeutic approaches of natural products for COVID-19: Computer-aided drug design perspective.
   Rahman MM, Islam MR, Akash S, Mim SA, et al · · 2022 · cited 18× · PMID 36072227 · DOI 10.3389/fcimb.2022.929430