Trial NCT04861298
Publication Di Pierro F, Int J Gen Med, 2021 (published paper)
Dates: 2020-12-01 to 2021-03-30
Funding: Private (Indena S.p.A. and Pharmextracta S.p.A.)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Pakistan Follow-up duration (days): 21 | |
| Inclusion criteria | 18 years or older of either gender; tested positive for COVID-19 shown by polymerase chain reaction (PCR); oxygen saturation higher than 93%; demonstrating symptoms associated with COVID-19 including fever, dyspnea, persistent dry cough, sore throat, myalgia, weakness, cold, rhinorrhea, and conjunctivitis of mild/moderate grade to be manageable with pharmacological therapy at home |
| Exclusion criteria | Receiving anti-retroviral therapy or immune system booster medications in the last 3 months; glucose-6-phosphate dehydrogenase (G6PD) deficiency; end-stage renal disease; terminal cancer |
| Interventions | |
| Treatment
Quercetin 1st week dose: 200 mg orally 3 times a day for the first 7 days -2nd week dose: 200 mg orally 2 times a day for the next 7 days |
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| Control
Standard care ( / ) Definition of Standard care: Analgesics/anti-fevers and antibiotics, as established by the hospital guidelines (acetaminophen 500–1000 mg/dose if body temperature was higher than 37.5 °C with a maximum daily dosage of 3 g/die; azithromycin 500 mg/die for 3 consecutive days). | |
| Participants | |
| Randomized 42 participants (n1=21 / n2= 21) | |
| Characteristics of participants N=42 Mean age : 49.4 20 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Testing negative for SARS-CoV-2 by RT-PCR with symptoms improvement [ Time Frame: From day 1 to day 14 ] | |
| In the report 1) time needed to become negative at the RT-PCR for SARS-CoV-2; 2) course of C-reactive protein (CRP), lactate dehydrogenase (LDH), ferritin, D-dimers, hemoglobin, white blood cells (WBC), platelets (PL), neutrophils (N) and lymphocytes (L); 3) course of COVID-19 related symptoms; 4) need of hospitalization | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
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| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
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| General comment |