Phase
Condition
Common Cold
Respiratory Syncytial Virus (Rsv) Infection
Covid-19
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Patients with RT-PCR diagnosis of COVID-19 or a clinical condition compatible with COVID-19and respiratory symptoms, presenting: A. Persistent dry cough associated with axillary temperature > 37.7 Celsius; OR B. Recent onset of Flu-like Respiratory Symptoms associated with dry cough OR C. Tomographic image compatible with COVID 19 infection; 2. Men and women aged > 50 years OR: Patients over 18 years of age with at least one of thefollowing 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 ArteryDisease, 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 (equivalentto at least 10 mg of oral prednisone per day)
- Willingness to comply with study related procedures
- Ability to provide informed consent before any protocol-related procedures.
Exclusion
Exclusion Criteria:
- RT-PCR exam for COVID-19 negative during the screening visit.
- Patients with an acute respiratory condition compatible with COVID-19 beinghospitalized;
- Patients with an acute respiratory condition and with moderate to high probability ofnot 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;
- Arterial Oxygen Saturation < 92% with nasal oxygen therapy at 10 l/ min;
- PaO2 / FIO2 <300 mmHg
- History of Cardiac Arrhythmia or Long QT Syndrome; 5. Use of Medications that are knownto prolong QTc: Citalopram, Venlafaxine, Bupropion and with no possibility of suspensionduring the period of investigational medical product administration. 6. Inability to takeoral medications; 7. Patients on continuous use of Amiodarone and / or PGE5 Inhibitors (Ex .: Sildenafil and similar). 8. Use of Digoxin, Cyclosporine, Cimetidine, Tamoxifen. 9. Useof anticonvulsants, antifungals, immunosuppressants other than corticotherapy. 10. Use ofHydroxychloroquine 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 Cclassification; 16. Patients with a history of degenerative retinal diseases (patients withretinal 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 severedegenerative neurological diseases and / or severe mental illness; 19. Inability of thepatient or representative to give consent or adhere to the procedures proposed in theprotocol; 20. Known hypersensitivity and / or intolerance to Hydroxychloroquine. 21.Hypersensitivity and / or intolerance Lopinavir / Ritonavir
Study Design
Study Description
Connect with a study center
CARDRESEARCH - Cardiologia Assistencial e de Pesquisa
Belo Horizonte, Minas Gerais 30150240
BrazilActive - Recruiting
Pontificia Universidade Catolica de Minas Gerais
Belo Horizonte, Minas Gerais 30535901
BrazilSite Not Available
Fundo Municipal de Saúde de Betim
Betim, Minas Gerais 32600412
BrazilActive - Recruiting
Universidade Federal de Ouro Preto
Ouro Preto, Minas Gerais 35400000
BrazilSite Not Available
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