Sagent COVID-19 Positive

  • STATUS
    Recruiting
Updated on 11 February 2021
covid-19
coronavirus
coronavirus infection

Summary

Treatment for COVID -19 positive subjects

Description

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial for the Treatment of Confirmed COVID-19 in Outpatients

Details
Condition Coronavirus, Covid-19, COVID-19, *Corona Virus
Clinical Study IdentifierTX265698
Last Modified on11 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults willing and able to provide informed consent before performing study procedures
Adults aged ≥ 18 years at time of informed consent
Subjects must have written notification of laboratory confirmed COVID-19 infection performed prior to screening
Have a mild or moderate form of COVID-19 defined as a SpO2 > 94% at screening
Subjects must have at least 1 of the following risk factors for severe illness: a.) Aged 65 years or older b.) Hypertension c.) Diabetes mellitus d.) Chronic lung disease including asthma, chronic obstructive pulmonary disease (COPD), and interstitial lung disease (e.g., idiopathic pulmonary fibrosis) e.) Chronic cardiac conditions, including coronary artery disease (CAD), heart failure, congenital heart disease, cardiomyopathy f.) Severe obesity (body mass index [BMI] ≥ 40 kg/m2) g.) Chronic liver disease, including cirrhosis
Must agree not to enroll in another study of an investigational agent or take any other drug that has been granted Emergency Use Authorization prior to completion of Day 28
If women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP, must be able and willing to use at least 1 highly effective method of contraception during the study and for 90 days after receiving the last dose of study drug. A female subject is considered to be a WOCBP following menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria

Physician makes a decision that trial involvement is not in subjects' best interest, or any condition that does not allow the protocol to be followed safely
Known severe liver disease (e.g., Child Pugh score > 12, AST > 5 times upper limit)
SaO2/SpO2 ≤ 94% in room air condition, or the arterial oxygen partial pressure (PaO2)/fractional inspired oxygen (FiO2) ratio < 300 mmHg
Known allergic reaction to camostat mesilate or one of its excipients
Known severe renal impairment or receiving dialysis
Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
Receipt of any experimental treatment for COVID-19, including agents with actual or possible direct acting antiviral activity
including, but not limited to, hydroxychloroquine, lopinavir/ritonavir, tocilizumab, ivermectin, or remdesivir within the 30 days prior to the time of the screening evaluation. No off-label use of a drug for COVID-19 is allowed
History of human immunodeficiency virus infection on highly active antiretroviral therapy
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How to participate?

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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