| |
Randomized Clinical Trial for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel (EPICOS)
|
| |
| |
https://clinicaltrials.gov/ct2/show/study/NCT04334928
The choice of Truvada for the study, according to the abstract, is the result of anecdotal evidence the medicine may be effective against COVID-19.
A new clinical trial is underway in Spain that will assess whether Truvada, a drug commonly used as PrEP for HIV prevention, can stave off COVID-19 infection among medical practitioners seeking to treat patients amid the pandemic.
If successful, the trial may have broader implications for the general public and not just health workers. But the next step would be awaiting the result of the trials before the drug is determined to be effective.
The study, which began April 1 and is expected to run through the summer, is being conducted at Ramón y Cajal University Hospital in Madrid and sponsored by the Spanish National AIDS Plan, an arm of the Spanish government.
An estimated 4,000 participants will participate in the study, each of whom are medical workers age 18 to 65 working in areas of Spain heavily afflicted with the coronavirus.
Dr. Jose Arribas, research director of HIV and infectious diseases at La Paz Hospital in Madrid, said in Spanish via email to the Washington Blade one underlying basis for testing Truvada against COVID-19 is his findings that relatively few HIV-positive people have the disease.
"We are seeing few cases of HIV-positive people with severe COVID-19," Arribas said. "This is surprising because the immune system of an HIV-positive person has similarities to that of older people who do have severe cases of COVID-19. Furthermore, there is evidence from in vitro studies that supports Truvada can have an immunomodulatory effect."
Asked whether Truvada could be used for everyone, not just health care workers, if shown to have a positive impact in the study, Arribas replied, "You have to wait for the results of the study before we can answer this question."
-------------------
Randomized Clinical Trial for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel (EPICOS)
https://clinicaltrials.gov/ct2/show/study/NCT04334928
Brief Summary:
Healthcare workers are particularly at risk of SARS-CoV-2. This study aims to assess the efficacy of a
daily single dose of tenofovir disoproxil fumarate (TDF) (245 mg)/ Emtricitabine (FTC) (200 mg),
a daily single dose of hydroxychloroquine (HC) (200 mg),
a daily single dose of TDF (245 mg)/FTC (200 mg) plus HC (200 mg)
versus placebo, during 12 weeks in:
(1) reducing the incidence of symptomatic disease and
(2) reducing clinical severity COVID-19 among hospital healthcare workers aged 18 to 65 years in public and private hospitals in Spain.
Recruitment Status : Active, not recruiting
First Posted : April 6, 2020
Last Update Posted : April 9, 2020
Detailed Description:
Healthcare workers are particularly at risk of SARS-CoV-2. In the absence of a vaccine, other strategies aiming to reduce the development of COVID-19 in the population, more specifically in healthcare workers is being sought. Administration of effective drugs to people at risk of developing an infectious disease is well accepted and is part of clinical practice. To date there are few on-going randomized clinical trial on Pre-exposure prophylaxis (PrEP) evaluating chloroquine and hydroxychloroquine efficacy for health care workers and other groups at high risk.
Existing recent and scarce literature shows that RNA synthesis nucleos(t)ide analogue inhibitors, acting as viral RNA chain terminators, like TDF, abacavir or lamivudine, amongst others, could have an effect against SARS-CoV-2 infection.
Worldwide, there is broad evidence of the use, safety and tolerability of hydroxychloroquine (200 mg) and TDF/FTC (245 mg/200 mg).
This study aims to assess the efficacy of a daily single dose of TDF (245 mg)/FTC (200 mg), a daily single dose of HC (200 mg), a daily single dose of TDF (245 mg)/FTC (200 mg) plus HC (200 mg) versus placebo, during 12 weeks in: (1) reducing the incidence of symptomatic disease and (2) reducing clinical severity COVID-19 among hospital healthcare workers aged 18 to 65 years in public and private hospitals in Spain. Sample size calculations are based on the primary outcome; number of symptomatic confirmed infections by SARS-CoV-2. Briefly, 4.000 participants will be assigned to one of the 4 groups, through 1:1:1:1 randomization. Duration of prophylactic treatment will be 12 weeks from early April 2020 till early July 2020. Follow up of participants will continue up to 4 weeks after last dose of treatment. All participants will be assessed on a monthly basis. Interim analyses will be performed on monthly bases.
Primary Outcome Measures:
1 Number of confirmed symptomatic infections of SARS-CoV-2 (COVID-19) [ Time Frame: 12 weeks ]
Secondary Outcome Measures :
1 Severity of disease in confirmed infected participants of SARS-CoV-2 (COVID-19) [ Time Frame: 12 weeks ]assessed by:
- No symptoms
- Mild symptoms: general malaise, fever, cough, myalgia, asthenia.
- Moderate symptoms: mild symptoms plus shortness of breath,
- Severe symptoms: mild symptoms plus respiratory insufficiency that requires admission in intensive care unit and mechanical ventilation
2
Duration of symptoms in confirmed infected participants of SARS-CoV-2 (COVID-19) measured in days [ Time Frame: 12 weeks ]
Investigators
Study Chair: Rosa Polo, MD,PhD Plan Nacional sobre el Sida (PNS)
Study Chair: Miguel Hernán, MD,PhD Harvard School of Public Health
Locations
Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
|
|
| |
| |
|
|
|
