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Covid19Phase 2NCT04530617

Camostat and Artemisia Annua vs Placebo in COVID-19 Outpatients

A Phase 2 study testing Camostat Mesilate and Artemisia Annua Leaf in people with Covid19 and Diabetes, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled, multi-arm, multicenter, phase II trial design to allow a rapid efficacy and toxicity assessment of potential therapies (camostat mesilate and artemisia annua) immediately after COVID-19 positive testing in mild to moderate disease and high-risk factors such as… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19, Diabetes, Hypertension
What is being tested?
Camostat Mesilate and Artemisia Annua Leaf
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
246 participants
Where
1 siteMexico
Study dates
5 Oct 2020to 10 Jun 2021
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years
  • Laboratory-confirmed SARS-CoV-2 infection within 3 days (of proposed consent) or the presence of symptoms or signs providing a high probability of COVID-19 disease who have symptoms within 7 days prior to diagnosis as determined by Infectious Disease specialist or treating physicians.
  • Outpatients. No previous hospitalization within the past 3 months.
  • Subjects must have at least one of the following high-risk features for clinical deterioration:
  • Hypertension
  • Diabetes mellitus
Show all 19Show fewer
  • Moderate to severe Chronic Obstructive Pulmonary Disease or asthma
  • Cancer patients who have received any immunosuppressive drugs within a year from enrollment.
  • Obesity as defined by a body mass index > 30 kg/m2.
  • Living in a nursing home or long-term facility
  • Underlying serious heart condition as determined by the treating physician
  • Immunocompromised subject as defined by the treating physician or by the Infectious Disease specialist
  • Ability to provide informed consent by the patient or healthcare proxy.
  • Ability to return for repeated testing and observation to the hospital.
  • Patients must have adequate organ and marrow function measured within the last 30 days as defined below:
  • platelets ≥100,000
  • aspartate transaminase or alanine transaminase ≤3 times institutional upper limit of normal
  • creatinine ≤ 1.5 times institutional upper limit of normal OR
  • glomerular filtration rate ≥45 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2

Who cannot join

  • Severe COVID-19 is defined by one or more of the following:
  • blood oxygen saturation ≤ 90%
  • partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
  • lung infiltrates ≥ 50% within 24 to 48 hours
  • Life-threatening COVID-19 is defined as one or more of the following:
  • respiratory failure
Show all 30Show fewer
  • septic shock
  • multiple organ dysfunction or failure
  • Weight less than 45 kg.
  • Pregnant or breast-feeding females
  • Subjects on dialysis or with creatinine clearance < 45 ml/min
  • Subjects who need antiviral administration due to severe viral diseases other than COVID-19, such as HIV, hepatitis B, and hepatitis C
  • Existing Division of Microbiology and Infectious Disease Toxicity Scale for determining the severity of adverse events grade 3 or greater.
  • Uncontrolled seizure disorder
  • Subjects with reflux esophagitis after chronic pancreatitis and gastrectomy surgery.
  • Patients with reflux esophagitis after surgery.
  • Known allergy to Artemisia annua or camostat mesilate.
  • Currently receiving any study medications for other indications.
  • Concurrent use of medication that would cause moderate or severe due to drug-drug interactions with study medication.
  • Specifically:
  • Patients receiving Artemisia annua tea may not be currently taking strong inducers of CYP2A6, including phenobarbital and rifampin.
  • Receipt in the 12 hours prior to enrollment, or planned administration during the 14-day study period that treating clinicians feel cannot be substituted for another medication, of any of the following: amiodarone; cimetidine; dofetilide; phenobarbital; phenytoin; or sotalol.
  • Cancer patients receiving active immunosuppressive treatment cannot be enrolled unless they are on a treatment holiday with no antineoplastic treatment with 3 weeks of enrollment.
  • Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • Subjects who have a history of drug and/or alcohol abuse within 52 weeks before screening
  • Enrollment on other experimental therapies for COVID-19.
  • Inability to receive enteral medications
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.
  • Subjects who have a history of drug and/or alcohol abuse within 52 weeks before screening
  • Any other condition that in the opinion of the treating physician justifies exclusion from the study.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

    Mexico City, None - Non-US/Canada, 14020

Other trials in Mexico

About this study

Official title: Randomized, Double-blind, Placebo-controlled, Multicenter, Multi-arm, Phase II Trial of Novel Agents for the Treatment of Mild to Moderate COVID-19 Positive Outpatients

This is a randomized, double-blind, placebo-controlled, multi-arm, multicenter, phase II trial design to allow a rapid efficacy and toxicity assessment of potential therapies (camostat mesilate and artemisia annua) immediately after COVID-19 positive testing in mild to moderate disease and high-risk factors such as diabetes, hypertension, and obesity among others.

Read the detailed description

Coronavirus Disease 2019 (COVID-19) is a highly contagious disease, caused by a novel enveloped RNA beta-coronavirus, also known as severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). This disease has caused a global health crisis.

While the majority of patients with COVID-19 develop a mild or uncomplicated illness, approximately 20-30% of hospitalized patients have required intensive care support and 5% of those have multi-organ failure or shock. The case fatality rate ranges from 1 to 4% and it is higher among those with pre-existing comorbid conditions (high-risk) such as cardiovascular disease, diabetes mellitus, obesity, chronic respiratory disease, hypertension, and cancer.

To date, treatments for COVID-19 in high-risk individuals remain experimental and therapeutic strategies to deal with the infection are at best supportive, with prevention aimed at reducing transmission in the community as the best weapon. No proven therapies have been demonstrated to prevent progression of COVID-19 to severe illness in confirmed outpatients with COVID-19 and this is a critical unmet need for high-risk individuals and warrants study. Furthermore, there are no effective medications for the use in outpatients with confirmed mild to moderate COVID-19 disease.

This is a randomized, double-blind, placebo-controlled, multi-arm, multicenter, phase II trial design to allow a rapid efficacy and toxicity assessment of potential therapies, camostat mesilate (serine protease inhibitor) and Artemisia annua (unknown mechanism) immediately after COVID-19 positive testing in mild to moderate disease and high-risk factors such as diabetes, hypertension, and obesity among others. The hypothesis of this study is that the addition of agents that inhibit viral entry or replication of SARS-CoV-2 virus, such as Artemisia annua and camostat, will reduce the rate of a composite outcome of hospitalization due to COVID-19 pneumonia or the use of oxygen therapy; will be devoid of additional moderate to severe toxicities; and will improve viral clearance at Day 14 in high-risk individuals. The main hypothesis is that the clinical outcomes in COVID-19 infected patients at higher risk of poor outcomes following infection will be improved compared to the standard of care when introduced as an early intervention after diagnosis.

Being tested
Camostat Mesilate, Artemisia Annua Leaf
Keywords
Covid19, Outpatients, High-risk
Medical subject headings
COVID-19, Diabetes Mellitus, Hypertension, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camostat MesilateDrug

    Also called Camostat

    Tablets

  • Artemisia Annua LeafDrug

    Also called Artemisia annua, Artemisia

    Tea bags

Study groups in NCT04530617
Study groupRoleWhat they receive
Camostat mesilateActive comparator100 mg tablet, 600 mg/day. Oral, 2 tablets three times a day, after a meal (600 mg total daily dose) Days 1-14.
Receives: Drug: Camostat Mesilate
Camostat PlaceboPlacebo comparatorMatched placebo
Receives: Drug: Camostat Mesilate
Artemisia annuaActive comparatorTea 225mg per bag,1350 mg/day. Oral, one 8 oz brewed tea (two bags) three times a day, Days 1-14.
Receives: Drug: Artemisia Annua Leaf
Artemisia annua PlaceboPlacebo comparatorMatched placebo
Receives: Drug: Artemisia Annua Leaf

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of hospitalizations and oxygen use

    Decrease in a composite outcome of hospitalization and supplemental oxygen use at day 14 between treatment pairs.

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2020
  2. Study start5 Oct 2020
  3. Primary completion10 Jun 2021
  4. Study completion10 Jun 2021

Why it stopped: Results from the interim analysis

Resources

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
A randomized, placebo-controlled, parallel, multicenter, multi-arm, phase II trial of novel agents for treatment of high-risk COVID-19 positive outpatients. Subjects who meet the inclusion/exclusion criteria and have properly signed the informed consent will be randomized to the test group or placebo group in the ratio of 1:1:1:1.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04530617
Sponsor's protocol ID
3421
Status last verified
Aug 2020
First submitted
26 Aug 2020
Last updated
21 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All IPD results in the publication

Publications

  • Becker RC. COVID-19 update: Covid-19-associated coagulopathy. J Thromb Thrombolysis. 2020 Jul;50(1):54-67. doi: 10.1007/s11239-020-02134-3. No abstract available.

    PubMed 32415579

  • Del Rio C, Malani PN. COVID-19-New Insights on a Rapidly Changing Epidemic. JAMA. 2020 Apr 14;323(14):1339-1340. doi: 10.1001/jama.2020.3072. No abstract available.

    PubMed 32108857

  • Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

    PubMed 31986264

  • Sohrabi C, Alsafi Z, O'Neill N, Khan M, Kerwan A, Al-Jabir A, Iosifidis C, Agha R. World Health Organization declares global emergency: A review of the 2019 novel coronavirus (COVID-19). Int J Surg. 2020 Apr;76:71-76. doi: 10.1016/j.ijsu.2020.02.034. Epub 2020 Feb 26.

    PubMed 32112977

  • Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

    PubMed 32109013

  • Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.

    PubMed 32167524

  • Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

    PubMed 32031570

  • Xu XW, Wu XX, Jiang XG, Xu KJ, Ying LJ, Ma CL, Li SB, Wang HY, Zhang S, Gao HN, Sheng JF, Cai HL, Qiu YQ, Li LJ. Clinical findings in a group of patients infected with the 2019 novel coronavirus (SARS-Cov-2) outside of Wuhan, China: retrospective case series. BMJ. 2020 Feb 19;368:m606. doi: 10.1136/bmj.m606.

    PubMed 32075786

  • Giacomelli A, Pezzati L, Conti F, Bernacchia D, Siano M, Oreni L, Rusconi S, Gervasoni C, Ridolfo AL, Rizzardini G, Antinori S, Galli M. Self-reported Olfactory and Taste Disorders in Patients With Severe Acute Respiratory Coronavirus 2 Infection: A Cross-sectional Study. Clin Infect Dis. 2020 Jul 28;71(15):889-890. doi: 10.1093/cid/ciaa330. No abstract available.

    PubMed 32215618

  • Garg S, Kim L, Whitaker M, O'Halloran A, Cummings C, Holstein R, Prill M, Chai SJ, Kirley PD, Alden NB, Kawasaki B, Yousey-Hindes K, Niccolai L, Anderson EJ, Openo KP, Weigel A, Monroe ML, Ryan P, Henderson J, Kim S, Como-Sabetti K, Lynfield R, Sosin D, Torres S, Muse A, Bennett NM, Billing L, Sutton M, West N, Schaffner W, Talbot HK, Aquino C, George A, Budd A, Brammer L, Langley G, Hall AJ, Fry A. Hospitalization Rates and Characteristics of Patients Hospitalized with Laboratory-Confirmed Coronavirus Disease 2019 - COVID-NET, 14 States, March 1-30, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):458-464. doi: 10.15585/mmwr.mm6915e3.

    PubMed 32298251

  • Ortiz-Brizuela E, Villanueva-Reza M, Gonzalez-Lara MF, Tamez-Torres KM, Roman-Montes CM, Diaz-Mejia BA, Perez-Garcia E, Olivas-Martinez A, Rajme-Lopez S, Martinez-Guerra BA, de-Leon-Cividanes NA, Fernandez-Garcia OA, Guerrero-Torres L, Torres-Gonzalez L, Carrera-Patino FA, Corral-Herrera EA, Hernandez-Alemon AN, Tovar-Vargas MLA, Serrano-Pinto YG, Espejo-Ortiz CE, Morales-Ortega ML, Lozano-Cruz OA, Cardenas-Fragoso JL, Vidal-Mayo JJ, Hernandez-Gilsoul T, Rivero-Sigarroa E, Dominguez-Cherit G, Cervantes-Villar LE, Ramos-Cervantes MDP, Ibarra-Gonzalez V, Calva-Mercado JJ, Sierra-Madero JG, Lopez-Iniguez A, Ochoa-Hein E, Crabtree-Ramirez BE, Galindo-Fraga A, Guerrero-Almeida ML, Ruiz-Palacios GM, Gulias-Herrero A, Sifuentes-Osornio J, Kershenobich-Stalnikowitz D, Ponce-de-Leon A. CLINICAL AND EPIDEMIOLOGICAL CHARACTERISTICS OF PATIENTS DIAGNOSED WITH COVID-19 IN A TERTIARY CARE CENTER IN MEXICO CITY: A PROSPECTIVE COHORT STUDY. Rev Invest Clin. 2020;72(3):165-177. doi: 10.24875/RIC.20000211.

    PubMed 32584326

  • Bhimraj A, Morgan RL, Shumaker AH, Lavergne V, Baden L, Cheng VC, Edwards KM, Gandhi R, Muller WJ, O'Horo JC, Shoham S, Murad MH, Mustafa RA, Sultan S, Falck-Ytter Y. Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19. Clin Infect Dis. 2020 Apr 27:ciaa478. doi: 10.1093/cid/ciaa478. Online ahead of print.

    PubMed 32338708

  • Yamaya M, Shimotai Y, Hatachi Y, Lusamba Kalonji N, Tando Y, Kitajima Y, Matsuo K, Kubo H, Nagatomi R, Hongo S, Homma M, Nishimura H. The serine protease inhibitor camostat inhibits influenza virus replication and cytokine production in primary cultures of human tracheal epithelial cells. Pulm Pharmacol Ther. 2015 Aug;33:66-74. doi: 10.1016/j.pupt.2015.07.001. Epub 2015 Jul 10.

    PubMed 26166259

  • Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.

    PubMed 32142651

  • Kawase M, Shirato K, van der Hoek L, Taguchi F, Matsuyama S. Simultaneous treatment of human bronchial epithelial cells with serine and cysteine protease inhibitors prevents severe acute respiratory syndrome coronavirus entry. J Virol. 2012 Jun;86(12):6537-45. doi: 10.1128/JVI.00094-12. Epub 2012 Apr 11.

    PubMed 22496216

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camostat Mesilate and Artemisia Annua Leaf in people with Covid19 and Diabetes, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

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 19 inclusion and 30 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 21 Jun 2021. 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 Mexico. 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. Some participants in this study may receive a placebo. 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: Results from the interim analysis). 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?

Rate of hospitalizations and oxygen use (time frame: 14 days). 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 NCT04530617, which also lists 29 linked publications.

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 21 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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