COVID-19Phase 3NCT04403100
Hydroxychloroquine and Lopinavir/ Ritonavir to Improve the Health of People With COVID-19: "The Hope Coalition - 1"
A Phase 3 study testing Hydroxychloroquine Sulfate Tablets, Lopinavir/ Ritonavir Oral Tablet and Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets in people with COVID-19 and Coronavirus Infection, run by Cardresearch at 4 sites in Brazil.
Trial summary
The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Coronavirus Infection, Virus Disease
- What is being tested?
- Hydroxychloroquine Sulfate Tablets, Lopinavir/ Ritonavir Oral Tablet and Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,968 participants
- Where
- 4 sitesBrazil
- Study dates
- 3 Jun 2020to 1 Feb 2021
- Phase
- Phase 3
- 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
- Patients with RT-PCR diagnosis of COVID-19 or a clinical condition compatible with COVID-19 and respiratory symptoms, presenting:
- Persistent dry cough associated with axillary temperature > 37.7 Celsius;
- OR
- Recent onset of Flu-like Respiratory Symptoms associated with dry cough
- OR
- Tomographic image compatible with COVID 19 infection;
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- 2. Men and women aged > 50 years OR: Patients over 18 years of age with at least one of the following criteria
- Diabetes requiring oral medication or insulin.
- Arterial hypertension requiring at least 01 oral medication for treatment
- Known cardiovascular diseases (CHF of any etiology, documented Coronary Artery Disease, Clinically overt heart disease)
- Symptomatic chronic lung disease and/ or medically controlled
- Patients with a history of transplantation
- Patient with stage IV chronic kidney disease or on dialysis.
- Patients on current Immunosuppression and/or using corticosteroid therapy (equivalent to at least 10 mg of oral prednisone per day)
- Willingness to comply with study related procedures
- 3. Ability to provide informed consent before any protocol-related procedures.
Who cannot join
- RT-PCR exam for COVID-19 negative during the screening visit.
- Patients with an acute respiratory condition compatible with COVID-19 being hospitalized;
- Patients with an acute respiratory condition and with moderate to high probability of not being a COVID infection 19;
- Dyspnea secondary to other acute and chronic respiratory causes or infections (eg, decompensated Chronic Obstructive Pulmonary Disease, acute bronchitis, pneumonia, primary pulmonary arterial hypertension);
- Severe respiratory clinical condition, presenting at least ONE of the criteria below:
- Respiratory Rate> 28 / min;
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- Arterial Oxygen Saturation < 92% with nasal oxygen therapy at 10 l/ min;
- PaO2 / FIO2 <300 mmHg
- 4. History of Cardiac Arrhythmia or Long QT Syndrome; 5. Use of Medications that are known to prolong QTc: Citalopram, Venlafaxine, Bupropion and with no possibility of suspension during the period of investigational medical product administration. 6. Inability to take oral medications; 7. Patients on continuous use of Amiodarone and / or PGE5 Inhibitors (Ex .: Sildenafil and similar). 8. Use of Digoxin, Cyclosporine, Cimetidine, Tamoxifen. 9. Use of anticonvulsants, antifungals, immunosuppressants other than corticotherapy. 10. Use of Hydroxychloroquine for other indications 11. Use of chemoprophylaxis for malaria. 12. Psoriasis in a form other than cutaneous 13. Porphyria 14. Use of protease inhibitors, ritonavir or Cobicistat 15. Clinical history of Liver Cirrhosis or Child-Pugh C classification; 16. Patients with a history of degenerative retinal diseases (patients with retinal diseases due to diabetes and hypertension can participate in the research); 17. Patient with a clinically relevant history of hearing loss; 18. Patients with known severe degenerative neurological diseases and / or severe mental illness; 19. Inability of the patient or representative to give consent or adhere to the procedures proposed in the protocol; 20. Known hypersensitivity and / or intolerance to Hydroxychloroquine. 21. Hypersensitivity and / or intolerance Lopinavir / Ritonavir
- -
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites, 4 recruiting
- Recruiting
CARDRESEARCH - Cardiologia Assistencial e de Pesquisa
Belo Horizonte, Minas Gerais, 30150240
Izabel Silva, SC, 553132416574, coordpesq@cardresearch.org
Gilmar Reis, MD,PhD
- Not yet recruiting
Pontificia Universidade Catolica de Minas Gerais
Belo Horizonte, Minas Gerais, 30535901
Eduardo Silva, MD, PhD, duduaugusto1@gmail.com
Eduardo Silva, MD, PhD
- Recruiting
Fundo Municipal de Saúde de Betim
Betim, Minas Gerais, 32600412
Daniela Silva, MD, PhD, 5531984923130, daninhamed@yahoo.com.br
Daniela Silva, MD, PhD
- Not yet recruiting
Universidade Federal de Ouro Preto
Ouro Preto, Minas Gerais, 35400000
Leonardo Savassi, MD, PhD, leosavassi@gmail.com
Leonardo Savassi, MD, PhD
About this study
Official title: Hydroxychloroquine and Lopinavir/ Ritonavir for Hospitalization and Mortality Reduction in Patients With COVID-19 and Mild Disease Symptoms: "The Hope Coalition"
The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV viral replication in experimental severe acute respiratory symptoms models and have similar activity against SARS-CoV2. Although widely used in studies of critically ill patients, to date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed patients with COVID-19 and mild symptoms.
Read the detailed description
In December 2019 a series of viral pneumonia cases were reported in the city of Wuhan, China. A new subtype of coronavirus has been identified as the causative agent of this condition. On February 11, 43,103 cases had already been described and on this day the World Health Organization (WHO) named this disease as COVID-19. With. The disease had spread out to several countries on different continents and on March 11, WHO declared a state of worldwide pandemic. Today (April 25, 2020) there are 2,719,897 cases and 187,705 deaths documented, with a global case-fatality ratio of 6.9%.
To date, no treatment has been identified as effective in combating this disease which has been identified as with high mortality, therefore there are no specific therapeutic options. So far, efforts have been focused on the treatment of patients hospitalized with dyspnea and, although several promising drugs are being evaluated, none has demonstrated effectiveness in reducing morbidity and mortality at this stage of the disease, suggesting that perhaps the best time to use medications either before the onset of severe symptoms of respiratory distress.
Thus, we propose the use of two drugs which experimentally have shown activity against SARS-CoV2 and being used in severely ill patients with COVID-19. Our hypothesis is that perhaps using such drugs before onset of complications will allow better outcomes on this patient population.
- Conditions
- COVID-19, Coronavirus Infection, Virus Disease, Acute Respiratory Infection, SARS-CoV Infection
- Being tested
- Hydroxychloroquine Sulfate Tablets, Lopinavir/ Ritonavir Oral Tablet, Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets, Placebo
- Medical subject headings
- COVID-19, Coronavirus Infections, Virus Diseases, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine Sulfate TabletsDrug
Tablets of 400 mg: Loading dose of 02 tablets followed by one tablet of 400 mg orally on the following 09 days
Lopinavir/ Ritonavir Oral TabletDrug
tablets of 200/ 50 mg; Loading dose of 04 tablets twice a day on day 1 followed by two tablets twice a day on the following 09 days
Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral TabletsDrug
Hydroxychloroquine Oral Tablet 400 mg: Loading dose of 02 tablets followed by one tablet of 400 mg orally on the following 09 days
plus
Lopinavir/ Ritonavir Oral Tablet of 200/ 50 mg: Loading dose of 04 tablets twice a day on day 1 followed by two tablets twice a day on the following 09 days
PlaceboDrug
Placebo tablets - 01 tablet twice daily from day 01 through day 10.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine Sulfate | Active comparator | Hydroxychloroquine 400 mg. Loading oral dose of 800 mg followed by orally dose of 400 mg/ day for the following 10 days Receives: Drug: Hydroxychloroquine Sulfate Tablets |
| Lopinavir/ Ritonavir | Active comparator | Lopinavir Ritonavir 200/ 50 mg Loading oral dose of 800/ 200 mg twice a day on day 1 followed by 400/100 mg orally twice a day for the following 9 days Receives: Drug: Lopinavir/ Ritonavir Oral Tablet |
| Hydroxychloroquine plus Lopinavir/ Ritonavir | Active comparator | Hydroxychloroquine 400 mg. Loading oral dose of 800 mg followed by orally dose of 400 mg/ day for the following 10 days
Plus
Lopinavir Ritonavir 200/ 50 mg Loading oral dose of 800/ 200 mg twice a day on day 1 followed by 400/100 mg orally twice a day for the following 9 days Receives: Drug: Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets |
| Placebo | Placebo comparator | Placebo
Twice a day from day 1 through day 10. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who were hospitalized for progression of COVID-19 disease
Hospitalization is defined as at least 24 hours of acute care in a hospital or similar acute care facility (emergency settings, temporary emergency facilities created for acute care of COVID-19 pandemic)
Measured: Measuring during 28-day period since randomization (Intention to treat analysis)
Proportion of participants who died due to COVID-19 progression and/ or complications
Measured: Measuring during 28-day period since randomization (Intention to treat analysis)
Secondary outcomes (9)
Proportion of participants with viral load change on 03, 07, 10 and 14 after randomization
Viral load change on 03, 07, 10 and 14 after randomization (200 patients per arm)
Measured: Measuring during 14-day period since randomization
Time to clinical improvement
Proportion of participants with clinical improvement, defined as normalization of temperature, Respiratory rate, SaO2, and cough relief (> 50% compared to baseline measured on a visual analog scale) in the last 72 hours.
Measured: Measuring during 28-day period since randomization
Time to clinical failure
Proportion of participants with clinical improvement, defined as as time to need for hospitalization due to dyspnea, death, need for mechanical ventilation, shock and need for vasoactive amines;
Measured: Measuring during 28-day period since randomization
Hospitalization for any cause
Proportion of participants with hospitalization for any cause
Measured: Measuring during 28-day period since randomization
Proportion of participants who died due to pulmonary complications
Measured: Measuring during 28-day period since randomization
Proportion of participants who died due to cardiovascular complications
Measured: Measuring during 28-day period since randomization
Proportion of participants who presented with adverse events
Evaluation of adverse events evaluated as associated to any of study arms
Measured: Measuring during 28-day period since randomization
Time to improvement on respiratory scale symptoms
Proportion of participants who presented sustained improvement on respiratory scale defined as at least 48 hours of improvement.
Measured: Measuring during 28-day period since randomization
proportion of non-adherent participants to any of study drugs
Measured: Measuring during 10-day period since randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start3 Jun 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Patients will be randomly allocated to one of four treatment arms in a 1:1:1:1 ratio: 1. Lopinavir / Ritonavir 2. Hydroxychloroquine 3. Lopinavir / Ritonavir + Hydroxychloroquine 4. Placebo. We will use a centralized random allocation schedule, generated by computer and implemented using an online remote access system. Randomization will be stratified by participating basic health unit.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,968 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardresearch
- Sponsor type
- University, hospital or other
- Collaborators
- Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA, Cytel Inc.
- Responsible party
- Principal investigator, Gilmar Reis, Cardresearch
- Investigators
- Gilmar Reis, MD, PhD, Principal investigator, Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403100
- Sponsor's protocol ID
- COVID19_AMB_Brasil
- Status last verified
- Jan 2021
- First submitted
- 23 May 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reis G, Moreira Silva EADS, Medeiros Silva DC, Thabane L, Singh G, Park JJH, Forrest JI, Harari O, Quirino Dos Santos CV, Guimaraes de Almeida APF, Figueiredo Neto AD, Savassi LCM, Milagres AC, Teixeira MM, Simplicio MIC, Ribeiro LB, Oliveira R, Mills EJ; TOGETHER Investigators. Effect of Early Treatment With Hydroxychloroquine or Lopinavir and Ritonavir on Risk of Hospitalization Among Patients With COVID-19: The TOGETHER Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e216468. doi: 10.1001/jamanetworkopen.2021.6468.
PubMed 33885775
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxychloroquine and Lopinavir/ Ritonavir for Hospitalization and Mortality Reduction in Patients With COVID-19 and Mild Disease Symptoms: "The Hope Coalition"
- ClinicalTrials.gov ID
- NCT04403100
- Acronym / sponsor ID
- COVID19_AMB_Brasil
- Conditions
- COVID-19, Coronavirus Infection, Virus Disease, Acute Respiratory Infection, SARS-CoV Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,968 participants (estimated)
- Lead sponsor
- CardresearchUniversity, hospital or other
- Collaborators
- Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA, Cytel Inc.
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV viral replication in experimental severe acute respiratory symptoms models and have similar activity against SARS-CoV2. Although widely used in studies of critically ill patients, to date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed patients with COVID-19 and mild symptoms.
Detailed description
In December 2019 a series of viral pneumonia cases were reported in the city of Wuhan, China. A new subtype of coronavirus has been identified as the causative agent of this condition. On February 11, 43,103 cases had already been described and on this day the World Health Organization (WHO) named this disease as COVID-19. With. The disease had spread out to several countries on different continents and on March 11, WHO declared a state of worldwide pandemic. Today (April 25, 2020) there are 2,719,897 cases and 187,705 deaths documented, with a global case-fatality ratio of 6.9%.
To date, no treatment has been identified as effective in combating this disease which has been identified as with high mortality, therefore there are no specific therapeutic options. So far, efforts have been focused on the treatment of patients hospitalized with dyspnea and, although several promising drugs are being evaluated, none has demonstrated effectiveness in reducing morbidity and mortality at this stage of the disease, suggesting that perhaps the best time to use medications either before the onset of severe symptoms of respiratory distress.
Thus, we propose the use of two drugs which experimentally have shown activity against SARS-CoV2 and being used in severely ill patients with COVID-19. Our hypothesis is that perhaps using such drugs before onset of complications will allow better outcomes on this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Patients will be randomly allocated to one of four treatment arms in a 1:1:1:1 ratio: 1. Lopinavir / Ritonavir 2. Hydroxychloroquine 3. Lopinavir / Ritonavir + Hydroxychloroquine 4. Placebo. We will use a centralized random allocation schedule, generated by computer and implemented using an online remote access system. Randomization will be stratified by participating basic health unit.
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine Sulfate | Active comparator | Drug: Hydroxychloroquine Sulfate TabletsHydroxychloroquine 400 mg. Loading oral dose of 800 mg followed by orally dose of 400 mg/ day for the following 10 days |
| Lopinavir/ Ritonavir | Active comparator | Drug: Lopinavir/ Ritonavir Oral TabletLopinavir Ritonavir 200/ 50 mg Loading oral dose of 800/ 200 mg twice a day on day 1 followed by 400/100 mg orally twice a day for the following 9 days |
| Hydroxychloroquine plus Lopinavir/ Ritonavir | Active comparator | Drug: Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral TabletsHydroxychloroquine 400 mg. Loading oral dose of 800 mg followed by orally dose of 400 mg/ day for the following 10 days Plus Lopinavir Ritonavir 200/ 50 mg Loading oral dose of 800/ 200 mg twice a day on day 1 followed by 400/100 mg orally twice a day for the following 9 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Twice a day from day 1 through day 10. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with RT-PCR diagnosis of COVID-19 or a clinical condition compatible with COVID-19 and respiratory symptoms, presenting:
- Persistent dry cough associated with axillary temperature > 37.7 Celsius;
- OR
- Recent onset of Flu-like Respiratory Symptoms associated with dry cough
- OR
Key exclusion criteria (10 listed)
- RT-PCR exam for COVID-19 negative during the screening visit.
- Patients with an acute respiratory condition compatible with COVID-19 being hospitalized;
- Patients with an acute respiratory condition and with moderate to high probability of not being a COVID infection 19;
- Dyspnea secondary to other acute and chronic respiratory causes or infections (eg, decompensated Chronic Obstructive Pulmonary Disease, acute bronchitis, pneumonia, primary pulmonary arterial hypertension);
- Severe respiratory clinical condition, presenting at least ONE of the criteria below:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine Sulfate TabletsTablets of 400 mg: Loading dose of 02 tablets followed by one tablet of 400 mg orally on the following 09 days | Drug | Hydroxychloroquine Sulfate |
| Lopinavir/ Ritonavir Oral Tablettablets of 200/ 50 mg; Loading dose of 04 tablets twice a day on day 1 followed by two tablets twice a day on the following 09 days | Drug | Lopinavir/ Ritonavir |
| Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral TabletsHydroxychloroquine Oral Tablet 400 mg: Loading dose of 02 tablets followed by one tablet of 400 mg orally on the following 09 days plus Lopinavir/ Ritonavir Oral Tablet of 200/ 50 mg: Loading dose of 04 tablets twice a day on day 1 followed by two tablets twice a day on the following 09 days | Drug | Hydroxychloroquine plus Lopinavir/ Ritonavir |
| PlaceboPlacebo tablets - 01 tablet twice daily from day 01 through day 10. | Drug | Placebo |
Primary outcome
Proportion of participants who were hospitalized for progression of COVID-19 disease
Time frame: Measuring during 28-day period since randomization (Intention to treat analysis)
Hospitalization is defined as at least 24 hours of acute care in a hospital or similar acute care facility (emergency settings, temporary emergency facilities created for acute care of COVID-19 pandemic)
Proportion of participants who died due to COVID-19 progression and/ or complications
Time frame: Measuring during 28-day period since randomization (Intention to treat analysis)
9 secondary outcomes
Proportion of participants with viral load change on 03, 07, 10 and 14 after randomization
Time frame: Measuring during 14-day period since randomization
Time to clinical improvement
Time frame: Measuring during 28-day period since randomization
Time to clinical failure
Time frame: Measuring during 28-day period since randomization
Hospitalization for any cause
Time frame: Measuring during 28-day period since randomization
Proportion of participants who died due to pulmonary complications
Time frame: Measuring during 28-day period since randomization
Proportion of participants who died due to cardiovascular complications
Time frame: Measuring during 28-day period since randomization
Proportion of participants who presented with adverse events
Time frame: Measuring during 28-day period since randomization
Time to improvement on respiratory scale symptoms
Time frame: Measuring during 28-day period since randomization
proportion of non-adherent participants to any of study drugs
Time frame: Measuring during 10-day period since randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Derived from this study: PubMed 33885775Reis G, Moreira Silva EADS, Medeiros Silva DC, Thabane L, Singh G, Park JJH, Forrest JI, Harari O, Quirino Dos Santos CV, Guimaraes de Almeida APF, Figueiredo Neto AD, Savassi LCM, Milagres AC, Teixeira MM, Simplicio MIC, Ribeiro LB, Oliveira R, Mills EJ; TOGETHER Investigators. Effect of Early Treatment With Hydroxychloroquine or Lopinavir and Ritonavir on Risk of Hospitalization Among Patients With COVID-19: The TOGETHER Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e216468. doi: 10.1001/jamanetworkopen.2021.6468.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilmar Reis, MD, PhD principal investigator
Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine Sulfate Tablets, Lopinavir/ Ritonavir Oral Tablet and Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets in people with COVID-19 and Coronavirus Infection, run by Cardresearch at 4 sites in Brazil.
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 16 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilmar Reis, MD, PhD (+5531332416574, greisbh@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who were hospitalized for progression of COVID-19 disease (time frame: Measuring during 28-day period since randomization (Intention to treat analysis)). The study lists 2 primary outcomes in all. 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 NCT04403100, which also lists 1 linked publication.
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 26 Jan 2021.