Table 1 Group-level characteristics of randomized clinical trials evaluating hydroxychloroquine or chloroquine as treatment for COVID-19.

From: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials

Acronym

Register ID

Setting

Treatment comparison

Treatment schedule

COVID-19 status

Age

Mortality (%)

Location

Blinding

Targeted sample size

Trial and publication statusa

   

Experimental arm (n)

Control arm (n)

        

Hydroxychloroquine

 REMAP-CAP

NCT02735707

ICUb

HCQ (61)

No treatment (81)

800 mg at 0 and 6 h, then 800 mg/day for up to 6 days

Confirmed and suspected

≥18 years

27.46

Internationalc

None

No fixed sample size

Completedd, not published

 

ChiCTR2000029559

Inpatient

HCQ (31)

No treatment (31)

200 mg twice a day for 5 days

Confirmed

≥18 years

0

China

Participant, caregiver

300

Completed and published

 

ChiCTR2000029868

Inpatient

HCQ (75)

No treatment (75)

1200 mg/day for 3 days, then 800 mg/day for 11–18 days

Confirmed

≥18 years

0

China

None

360

Completed and published

 

NCT04261517

Inpatient

HCQ (15)

No treatment (15)

400 mg/day for 5 days

Confirmed

≥18 years

0

China

None

30

Completed and published

 RECOVERY

NCT04381936

Inpatient

HCQ (1561)

No treatment (31,55)

800 mg at 0 h, then 800 mg after 6 h, then 800 mg/day for up to 9 days

Confirmed and suspected

≥18 years

25.67

Europe

None

12,000e

Completedd and published

 

ChiCTR2000030054

Inpatient

HCQ (18)

No treatment (12)

400 mg/day for 10 days

Confirmed

18–75 years

0

China

None

100

Completed and published

 NO COVID-19

NCT04316377

Inpatient

HCQ (27)

No treatment (26)

800 mg/day for 7 days

Confirmed

≥18 years

3.77

Norway

None

202

Halted and published

 

NCT04384380

Inpatient

HCQ (21)

No treatment (12)

800 mg/day for 1 day, then 400 mg/day for 6 days

Confirmed

20–79 years

0

Taiwan

None

45

Completed and published

 

NCT04353336

Inpatient

HCQ (97)

No treatment (97)

800 mg/day for 1 day, then 400 mg/day for 14 days

Confirmed

All

5.67

Egypt

None

40

Recruiting and published

 Coalition I

NCT04322123

Inpatient

HCQ (221)

No treatment (227)

800 mg/day for 7 days

Confirmed and suspected

≥18 years

2.90

Americas

None

630e

Completed and published

 TEACH

NCT04369742

Inpatient

HCQ (67)

Placebo (61)

800 mg/day for 1 day, then 400 mg/day for 4 days

Confirmed

≥12 years

10.16

United States

Participant, caregiver

626

Terminated and published

 

NCT04491994

Inpatient

HCQ (349)

No treatment (151)

400 mg twice a day for 1 day, then 200 mg twice a day for 4 days

Confirmed

≥18 years

0

Pakistan

None

540

Completed and published

 WHO SOLIDARITY

2020-001366-11

Inpatient

HCQ (947)

No treatment (906)

Day 1, 2000 mg (hour 0, 800 mg; hour 6, 800 mg; hour 12, 400 mg), thereafter 800 mg per day for 10 days

Confirmed

≥18 years

10.15

International

None

10,000e

Terminated and published

 PATCH

NCT04329923

Inpatient

HCQ (15)

Placebo (15)

800 mg/day for up to 14 days

Confirmed

≥40 years

0

United States

Participant, caregiver

400e

Recruiting, not published

 CCAP-1

NCT04345289

Inpatient

HCQ (1)

Placebo (1)

600 mg/day for 7 days

Confirmed

≥18 years

0

Denmark

Participant, caregiver

1500e

Terminated, not published

 

NCT04335552

Inpatient

HCQ (4)

No treatment (2)

800 mg/day for 1 day, then 600 mg/day for 4 days

Confirmed

≥12 years

16.67

United States

None

500

Terminated, not published

 

HCQ + azithromycin (2)

Azithromycin (3)

800 mg/day for 1 day, then 600 mg/day for 4 days

60

 ARCHAIC

NL8490

Inpatient

HCQ (4)

No treatment (3)

800 mg/day for 1 day, then 400 mg/day for 4 days

Confirmed

≥18 years

28.57

Netherlands

None

950

Terminated, not published

 HYDRA

NCT04315896

Inpatient

HCQ (75)

Placebo (77)

400 mg/day for 10 days

Confirmed

18–80 years

37.50

Mexico

Participant, caregiver

500

Recruiting, not published

 PROTECT

NCT04338698

Inpatient

HCQ + azithromycin + oseltamivir (64)

Azithromycin + oseltamivir (64)

600 mg/day for 5 days

Confirmed

≥18 years

0

Pakistan

Investigator

500

Recruiting, not published

HCQ + oseltamivir (62)

Oseltamivir (63)

0.80

HCQ + azithromycin (59)

Azithromycin (61)

2.50

 OAHU-COVID19

NCT04345692

Inpatient

HCQ (10)

No treatment (6)

800 mg/day on day 1, then 400 mg/day for 4 days

Confirmed

18–95 years

12.50

United States

None

350

Recruiting, not published

 HYCOVID

NCT04325893

Inpatient

HCQ (124)

Placebo (123)

800 mg on day 1, then 400 mg/day for 8 days

Confirmed

≥18 years

6.88

France

Participant, caregiver

1300

Terminated, and not published

 COV-HCQf

NCT04342221

Inpatient

HCQ (13)

Placebo (14)

800 mg/day for day 1 and 600 mg/day for days 2–7

Confirmed

≥18 years

3.70

Germany

Participant, caregiver

220

Recruiting, not published

 COVID-PEP

NCT04308668

Outpatient

HCQ (244)

Placebo (247)

800 mg at 0  h, then 600 mg after 6–8 h, then 600 mg daily for 4 days

Confirmed and auspected

≥18 years

0.41

Internationalc

Participant, caregiver

3000

Completed and published

 BCN PEP CoV-2 Study

NCT04304053

Outpatient

HCQ (136)

No treatment (157)

800 mg on day 1, and 400 mg on days 2–7

Confirmed

≥18 years

0

Spain

None

2300

Completed and published

 

NCT04333654

Outpatient

HCQ (5)

Placebo (3)

800 mg at 0  h, then 400 mg 6–8 h later, then 600 mg/day for 9 days

Confirmed

18–80 years

0

Internationalc

Participant, caregiver

210

Terminated, not published

 COMIHY

NCT04340544

Outpatient

HCQ (8)

Placebo (8)

600 mg/d for 7 days

Confirmed

≥18 years

0

Germany

Participant, caregiver

2700

Recruiting, not published

Chloroquine

 

ChiCTR2000030054

Inpatient

CQ (18)

No treatment (12)

1000 mg/day for 1 day, then 500 mg/day for 9 days

Confirmed

18–75 years

0

China

None

100

Completed and published

 ARCHAIC

NL8490

Inpatient

CQ (5)

No treatment (3)

600 mg at 0 h, then 300 mg after 12 h, then 600 mg/day for 4 days

Confirmed

≥18 years

12.50

Netherlands

None

950

Terminated, not published

 CloroCOVID19II

NCT04342650

Outpatient

CQ (78)

Placebo (74)

900 mg/day for 1 day, then 450 mg/day for 4 days

Suspected

≥18 years

0

Brazil

Participant, caregiver

210

Completed, not published

 CloroCOVID19III

NCT04323527

Inpatient

CQ (41)

Placebo (41)

900 mg/day for 1 day, then 450 mg/day for 4 days

Suspected

≥18 years

35.37

Brazil

Participant, caregiver

278

Completed, not published

 

ChiCTR2000031204

Inpatient

CQ (18)

Placebo (17)

1000 mg on day 1, then 500 mg/day on days 2–3, then 250 mg/day until ≤14 days of total treatment

Confirmed

18 to 70 years

0

China

Participant

300

Recruiting, not published

  1. CQ chloroquine, HCQ hydroxychloroquine.
  2. In all trials that used hydroxychloroquine, dosages refer to hydroxychloroquine sulfate. In trials that used chloroquine, the dosages for ARCHAIC, ChiCTR2000030054 and ChiCTR2000031204 refer to chloroquine phosphate, while those for CloroCOVID19II and CloroCOVID19III refer to chloroquine base.
  3. aIncluding peer-reviewed journal publications and posted preprints.
  4. bExcept one study site (University of Pittsburgh Medical Center) that recruited patients in a general ward setting.
  5. cIncluding centers in multiple countries.
  6. dOther arms of the trial are still ongoing.
  7. eTrial includes more treatment arms than reported here; target sample size refers to all arms.
  8. fThe allocation of participants to the experimental arm (n = 13) and control arm (n = 14) versus experimental arm (n = 14) and control arm (n = 13) was not yet unblinded. The allocation for the meta-analysis was done randomly. A sensitivity analysis with the reverse assignment gave the same result.