Table 6.
Characteristics of ongoing clinical trials studying the efficacy and safety of CQ and HCQ in patients with COVID-19.
| Drug | Design | Status | Group(s) | Total No | Primary outcomes | Country Registration No. |
|---|---|---|---|---|---|---|
| HCQ | Interventional ROLCS |
Completed | Conventional treatment HCQ |
360 | Viral clearance | China ChiCTR2000029868 |
| HCQ | Interventional ROLCS |
Recruiting | Conventional treatment HCQ |
78 | Clinical status | China ChiCTR2000029740 |
| HCQ | Interventional RDBS | Recruiting | Placebo HCQ |
300 | Viral clearance T cell recovery time |
China ChiCTR2000029559 |
| HCQ | Retrospective Observational | Not yet recruiting | HCQ | 1200 | Pneumonia incidence | China ChiCTR2000031782 |
| HCQ | Interventional ROLS | Completed | Conventional treatment HCQ |
30 | Viral clearance Mortality |
China NCT04261517 |
| CQ | Interventional RROLCS |
Recruiting | Control CQ |
80 | Clinical recovery time | China ChiCTR2000030718 |
| CQ | Interventional RCT |
Recruiting | Placebo CQ/FAV FAV |
150 | Improvement or recovery Viral clearance | China ChiCTR2000030987 |
| CQ | Interventional RRSBCS |
Recruiting | Placebo CQ |
300 | Viral clearance | China ChiCTR2000031204 |
| CQ | Interventional ROLCS |
Not yet recruiting | HCQ Arbidol |
320 | No. patients progressed to suspected/confirmed | China ChiCTR2000029803 |
| CQ | Interventional RSBCS |
Recruiting | Conventional/CQ CQ |
100 | Length of hospital stay | China ChiCTR2000029939 |
| CQ | Interventional SAOLS |
Recruiting | Conventional/CQ | 100 | Length of hospital stay | China ChiCTR2000029935 |
| CQ | Interventional OLS |
Not yet recruiting | LPV/RTV CQ/LPV/RTV CQ |
205 | Viral clearance | China ChiCTR2000029609 |
| CQ | Interventional cohort study | Recruiting | Conventional treatment CQ |
20 | Viral clearance Mortality |
China ChiCTR2000029542 |
| CQ | Interventional ROLCS |
Recruiting | LPV/RTV CQ |
112 | Clinical status Mortality Viral clearance |
China ChiCTR2000029741 |
| CQ | Interventional OLS | Recruiting | Control CQ |
80 | Clinical recovery time | China ChiCTR2000029988 |
| CQ | Interventional SAOLS | Not yet recruiting | CQ | 10 | Viral clearance Mortality |
China ChiCTR2000029975 |
| CQ | Interventional RDBPCS | Recruiting | Placebo FAV CQ/FAV |
150 | Time to and frequency of improvement or recovery Viral clearance |
China NCT04319900 |
| CQ | Interventional ROLCS | Not yet recruiting | Carrimycin CQ LPV/RTV Arbidol |
520 | Fever HRCT Viral clearance |
China NCT04286503 |
| HCQ CQ | Interventional ROLCS |
Recruiting | CQ HCQ |
100 | Clinical recovery time | China ChiCTR2000029899 |
| HCQ CQ | Interventional ROLCS |
Recruiting | CQ HCQ |
100 | Clinical recovery time | China ChiCTR2000029898 |
| HCQ CQ | Interventional ROLS |
Not yet recruiting | Conventional treatment HCQ CQ |
100 | Clinical recovery time | China ChiCTR2000030054 |
| HCQ CQ | Interventional ROLS | Not yet recruiting | Conventional treatment CQ HCQ |
100 | Clinical recovery time Viral clearance |
China ChiCTR2000029992 |
| HCQ | Interventional RCT | Not yet recruiting | Placebo HCQ |
1600 | No. symptomatic confirmed cases | USA NCT04318444 |
| HCQ | Interventional ROLS |
Not yet recruiting | Standard of care HCQ AZT HCQ/AZT |
500 | Clinical status | USA NCT04335552 |
| HCQ | Interventional OLS | Not yet recruiting | HCQ Vit C Vit D Zinc |
600 | Viral clearance Blood pressure Presence of side effects |
USA NCT04335084 |
| HCQ | Interventional RCT | Recruiting | HCQ Vit C |
1250 | Hospitalization IMV |
USA NCT04334967 |
| HCQ | Interventional OLS | Not yet recruiting | HCQ/AZT/Vit C/Vit D/Zinc | 60 | Symptoms resolution Viral clearance Safety |
USA NCT04334512 |
| HCQ | Interventional ROLS | Recruiting | HCQ AZT |
1550 | Hospital admission | USA NCT04334382 |
| HCQ | Interventional RDBPCS | Recruiting | Placebo HCQ |
210 | Viral clearance | USA NCT04333654 |
| HCQ | Interventional OLS | Recruiting | HCQ Control |
360 | Rate of positivity | USA NCT04333225 |
| HCQ | Interventional ROLS |
Not yet recruiting | Standard of care HCQ HCQ/AZT |
160 | Viral clearance | USA NCT04336332 |
| HCQ | Interventional RDBPCS |
Recruiting | Placebo HCQ |
510 | Clinical status | USA NCT04332991 |
| HCQ | Interventional RDBPCS ROLCS |
Not yet recruiting | Placebo HCQ |
400 | Quarantine release rate Hospital discharge rate Infection rate |
USA NCT04329923 |
| HCQ | Interventional RCT | Recruiting | Placebo HCQ |
3500 | Survival/recovery | USA NCT04328467 |
| HCQ | Interventional RDBPCS | Recruiting | Placebo HCQ LPV/RTV LST |
4000 | Clinical status | USA NCT04328012 |
| HCQ | Interventional ROLS |
Recruiting | HCQ AZT |
300 | Clinical status | USA NCT04329832 |
| HCQ | Interventional RSBS | Not yet recruiting | Ascorbic Acid HCQ |
2000 | Viral clearance | USA NCT04328961 |
| HCQ CQ |
Interventional ROLCS | Recruiting | HCQ HCQ/AZT CQ CQ/AZT |
500 | Recovery | USA NCT04341727 |
| HCQ | Interventional RCT | Recruiting | Placebo HCQ |
3000 | Incidence in asymptomatic Severity |
USA/Canada NCT04308668 |
| HCQ CQ |
Interventional RDBPCS |
Not yet recruiting | Placebo CQ HCQ |
55000 | Disease severity | USA, Australia, Canada, Ireland, South Africa, UK NCT04333732 |
| HCQ | Interventional OLS | Not yet recruiting | Standard of care LPV/RTV HCQ Baricitinib Sarilumab |
1000 | Clinical status | Canada NCT04321993 |
| HCQ | Interventional RDBPCS | Not yet recruiting | Placebo HCQ |
1660 | Hospitalization IMV Mortality |
Canada NCT04329611 |
| CQ | Interventional ROLCS | Not yet recruiting | Standard of care CQ/AZT |
1500 | Outpatients: admission or death Inpatients: IMV or death |
Canada NCT04324463 |
| HCQ | Interventional RDBPCS | Not yet recruiting | Placebo HCQ LPV/RTV |
1200 | Confirmed infection in HCW | France NCT04328285 |
| HCQ | Interventional RDBPCS | Recruiting | Placebo HCQ |
1300 | Mortality IMV |
France NCT04325893 |
| HCQ | Interventional ROLS | Recruiting | Standard of care RDV LPV/RTV LPV/RTV/IFβ-1a HCQ |
3100 | Clinical status | France NCT04315948 |
| HCQ | Interventional ROLCS | Recruiting | RDV LPV/RTV IFβ-1a HCQ |
3100 | Clinical status | France EudraCT 2020-000936-23 |
| HCQ | – | Recruiting | HCQ | 25 | Viral clearance | France EudraCT 2020-000890-25 |
| HCQ | Interventional OLCS | Recruiting | Standard of care HCQ/AZT |
1000 | Incidence Mortality |
France EudraCT 2020-001250-21 |
| HCQ | Interventional RDBPCS | Recruiting | Placebo HCQ |
1300 | IMV Death |
France EudraCT 2020-001271-33 |
| HCQ | – | Recruiting | HCQ | 50 | HCQ pharmacokinetics | France EudraCT 2020-001281-11 |
| CQ | Interventional CSS | Recruiting | Any drug used to treat Covid-19 including CQ | 1000 | Renal failure | France NCT04314817 |
| CQ | Interventional ROLCS | Recruiting | Standard of care CQ analogue NIVO TCZ |
273 | Survival rate | France NCT04333914 |
| HCQ | Interventional RDBS | Not yet recruiting | HCQ/LPV/RTV HCQ/LPV/RTV/LEV/BUD/FORM |
30 | Chest CT-scan Viral clearance |
Iran NCT04331470 |
| HCQ | Interventional ROLCS | Recruiting | HCQ/LPV/RTV HCQ/LPV/RTV/IFβ-1b |
30 | Clinical status Lab/radiological findings Adverse reactions |
Iran IRCT20100228003449N27 |
| HCQ | Interventional ROLCS | Recruiting | HCQ/LPV/RTV HCQ/LPV/RTV/IFβ-1a |
30 | Clinical status Lab/radiological findings Adverse reactions |
Iran IRCT20100228003449N28 |
| HCQ | Interventional ROLCS | Recruiting | HCQ/LPV/RTV HCQ/LPV/RTV/SOF/LDV |
50 | Clinical status Lab/radiological findings Adverse reactions |
Iran IRCT20100228003449N29 |
| HCQ | Interventional SAOLS | Recruitment completed | HCQ/OTV/LPV/RTV/IFβ-1a | 20 | Clinical status | Iran IRCT20151227025726N12 |
| HCQ | Interventional SAOLS | Recruiting | HCQ/LPV/RTV HCQ/ATV/RTV |
50 | Clinical status Lab/radiological findings Adverse reactions |
Iran IRCT20100228003449N30 |
| HCQ | Interventional ROLCS | Not yet recruiting | Standard of care HCQ HCQ/AZT |
630 | Clinical status | Brazil NCT04322123 |
| HCQ | Interventional ROLS | Recruiting | HCQ HCQ/AZT |
440 | Clinical status | Brazil NCT04321278 |
| HCQ | Interventional OLS |
Not yet recruiting | HCQ/AZT | 400 | Evolution of ARS, SpO2, hemodynamic stability | Brazil NCT04329572 |
| CQ | Interventional RDBS | Recruiting | Low Dose CQ High Dose CQ |
440 | Mortality | Brazil NCT04323527 |
| HCQ | Interventional OLCS | Not yet recruiting | RDV HCQ HCQ/RDV |
700 | Mortality | Norway NCT04321616 |
| HCQ | Interventional ROLCS | Recruiting | Standard of care HCQ |
202 | Viral clearance | Norway NCT04316377 |
| HCQ | Interventional RCT | Recruiting | Standard of care HCQ/RDV |
443 | Safety and efficacy | Norway EudraCT 2020-000982-18 |
| HCQ | Interventional ROLCS | Recruiting | Standard of care HCQ |
200 | Viral clearance | Norway EudraCT 2020-001010-38 |
| HCQ | Interventional ROLCS | Recruiting | Standard measures HCQ/DRV/COBI |
3040 | Incidence of secondary cases | Spain NCT04304053 |
| HCQ | Interventional RDBPCS |
Not yet recruiting | Placebo HCQ TDF/FTC HCQ/TDF/FTC |
4000 | Confirmed symptomatic infections | Spain NCT04334928 |
| HCQ | Interventional RDBPCS | Recruiting | Placebo HCQ |
440 | No. confirmed cases | Spain NCT04331834 |
| HCQ | Interventional ROLCS | Recruiting | HCQ/AZT HCQ/AZT/TCZ |
276 | Mortality IMV |
Spain NCT04332094 |
| HCQ | Interventional ROLCS | Recruiting | LPV/RTV Dexamethasone IFβ-1a HCQ |
2000 | Mortality | UK EudraCT 2020-001113-21a |
| HCQ | Interventional ROLCS | Recruiting | Standard of care HCQ |
350 | Change in SpO2/FiO2 | UK EudraCT 2020-001270-29 |
| HCQ | Interventional RPCS | Recruiting | Placebo HCQ |
3000 | Hospital admission Mortality |
UK EudraCT 2020-001209-22 |
| HCD CQ |
Interventional RDBPCS | Not yet recruiting | Placebo CQ or HCQ |
40,000 | No. symptoms Severity |
UK NCT04303507 |
| HCQ | Interventional ROLCS | Recruiting | No intervention control LPV/RTV HCQ |
150 | Viral clearance | Korea NCT04307693 |
| HCQ | Interventional ROLCS | Not yet recruiting | Control CIC HCQ/CIC |
141 | Viral clearance | Korea NCT04330586 |
| HCQ | Interventional RCT |
Not yet recruiting | Control HCQ |
2486 | Incidence | Korea NCT04330144 |
| HCQ | Interventional RPCS | Not yet recruiting | Placebo HCQ |
2700 | Clinical status | Germany NCT04340544 |
| HCQ | Interventional RPCS | Recruiting | Placebo HCQ |
220 | Viral clearance | Germany NCT04342221 |
| HCQ | Interventional RPCS |
Not yet recruiting | Placebo/HCQ HCQ/COBI |
334 | Hospital admission | Germany NCT04338906 |
| HCQ | Interventional RDBPCS | Ongoing | Placebo HCQ |
220 | Viral clearance | Germany EudraCT 2020-001224-33 |
| HCQ | SAOLS | Recruiting | HCQ | 150 | Dose optimization | Australia ACTRN12620000447954 |
| HCQ | Interventional RCT |
Not yet recruiting | Control HCQ LPV/RTV HCQ/LPV/RTV |
2500 | No. patients not admitted to ICU | Australia ACTRN12620000445976 |
| CQ | Interventional ROLCS |
Not yet recruiting | CQ | 680 | Sick days of HCW | Australia ACTRN12620000417987 |
| HCQ | Interventional RTBCS | Not yet recruiting | Placebo HCQ |
400 | Infection rate | Mexico NCT04318015 |
| HCQ | Interventional RDBPCS | Not yet recruiting | Placebo HCQ |
500 | Mortality | Mexico NCT04315896 |
| HCQ | Interventional ROLCS | Not yet recruiting | Control HCQ |
1116 | Development of severe infection or death | Israel NCT04323631 |
| CQ | Interventional ROLS | Not yet recruiting | Standard of care CQ |
210 | Viral clearance Clinical status |
Israel NCT04333628 |
| HCQ | Observational CCPS |
Recruiting | HCQ | 80 | Protection | Turkey NCT04326725 |
| HCQ | Interventional ROLCS | Not yet recruiting | Convalescent Plasma/HCQ/AZT HCQ/AZT |
80 | Viral clearance IgM titers IgG titers |
Colombia NCT04332835 |
| HCQ | Interventional ROLS | Not yet recruiting | Quarantine/no treatment HCQ/OTV OTV/LPV/RTV HCQ/OTV/DRV/RTV FAV/LPV/RTV HCQ/FAV/DRV/RTV |
80 | Viral clearance | Thailand NCT04303299 |
| HCQ | Interventional SAOLS | Recruiting | HCQ/LPV/RTV ± OTV | 50 | CRP level | Japan jRCTs031190227 |
| CQ | Interventional OLS | Recruiting | CQ | 60 | Symptoms reduction Pneumonia prevention |
Greece EudraCT 2020-001345-38 |
| CQ | Interventional ROLCS | Not yet recruiting | Standard of care CQ |
250 | Viral clearance | Vietnam NCT04328493 |
| HCQ CQ |
Interventional RSBCS | Not yet recruiting | Natural Honey LPV/RTV Arbidol HCQ CQ OTV ± AZT |
1000 | Viral clearance Fever Resolution of lung inflammation |
Egypt NCT04323345 |
| HCQ | Interventional RSBCS | Not yet recruiting | Placebo HCQ/AZT HCQ |
75 | Clinical status | Pakistan NCT04328272 |
| HCQ | Observational Randomized Trial | Not yet recruiting | Control HCQ AZT OTV HCQ/AZT HCQ/OTV AZT/OTV HCQ/AZT/OTV |
500 | Viral clearance | Pakistan NCT04338698 |
| HCQ CQ |
Interventional ROLCS | Not yet recruiting | Standard of care HCQ CQ |
950 | Disease progression Admission to ICU or death |
Netherlands Trial NL8490 |
| HCQ | Interventional RDBPCS | Recruiting | Placebo HCQ/AZT |
226 | Survival Hospitalization |
Denmark NCT04322396 |
| HCQ | Interventional ROLCS |
Recruiting | Control HCQ HCQ/LPV/RTV Wide range of drugsb |
6800 | Mortality Days alive and outside ICU |
New Zealand NCT02735707 |
| HCQ | Interventional RDBPCS |
Not yet recruiting | Placebo HCQ |
440 | Viral clearance | Austria NCT04336748 |
| CQ | Interventional ROLCS |
Not yet recruiting | CQ/OTV RTV/DRV/OTV LPV/RTV/OTV FAV/LPV/RTV CQ/RTV/DRV/OTV CQ/RTV/DRV/FAV Quarantine |
440 | Viral clearance | Austria NCT04303299 |
| CQ | Interventional ROLCS | Not yet recruiting | Standard of care CQ |
400 | Hospitalization or all causes of death | Poland NCT04331600 |
ROLCS: Randomized open label controlled study; RDBS: Randomized double blind study; ROLS: Randomized open label study; RROLCS: Retrospective randomized open label controlled study; RCT: Randomized clinical trial; RRSBCS: Retrospective randomized single blind controlled study; RSBCS: Randomized single blind controlled study; SAOLS: Single arm open label study; OLS: Open label study; RDBPCS: Randomized double blind placebo controlled study; RSBS: Randomized single blind study; OLCS: Open label controlled study; CSS: Cross-sectional study; RPCS: Randomized placebo controlled study; RTBCS: Randomized triple blind controlled study; CCPS: Case-control prospective study.
HCQ: Hydroxychloroquine; CQ: Chloroquine; FAV: Favipiravir; LPV: Lopinavir; RTV: Ritonavir; AZT: Azithromycin; Vit C: Vitamin C; Vit D: Vitamin D; LST: Losartan; RDV: Remdesivir; IFß-1a: Interferon β-1a; NIVO: Nivolumab; TCZ: Tocilizumab; LEV: Levamisole; BUD: Budesonide; FORM: Formoterol; SOF: Sofosbuvir; LDV: Ledipasvir; OTV: Oseltamivir; ATV: Atazanavir; COBI: Cobicistat; TDF: Tenofovir disoproxil fumarate; FTC: Emtricitabine; CIC: Ciclesonide; DRV: Darunavir.
HRCT: Pulmonary inflammation resolution time, IMV: invasive mechanical ventilation; HCW: Healthcare workers;; ARS: Acute respiratory syndrome; SpO2/FiO2: oxygen saturation/fraction of inspired oxygen ratio; ICU: Intensive Care Unit; CRP: C-reactive protein.
Data were obtained from NIH. U.S. National Library of Medicine (https://www.clinicaltrials.gov/); the Chinese Clinical Trial Registry (http://www.chictr.org.cn/); the European Union Clinical Trials Registry (https://www.clinicaltrialsregister.eu); ISRCTN registry (http://www.isrctn.com/); Netherlands Trial Registry (https://www.trialregister.nl/); Iranian Registry for Clinical Trials (IRCT) (https://en.irct.ir/); Japanese Registry for Clinical Trials (JRCT) (https://jrct.niph.go.jp/) and the Australian New Zealand Clinical trial Registry (ANZCTR) (https://www.anzctr.org.au/).
a
The same study was registered in ISRCTN registry (registration no. ISRCTN50189673) with a total number of 5000 patients.
b
Hydrocortisone, Ceftriaxone, Moxifloxacin or Levofloxacin, Piperacillin-tazobactam, Ceftaroline, Amoxicillin-clavulanate, Macrolide, OTV, IFβ-1a, and Anakinra.