This is an HTML version of an attachment to the Official Information request 'Hydroxychloroquine removal from COVID-19 treatment clinical trials'.

4 November 2021
 [FYI request #17126 email]
Tēnā koe Maxwell
Official Information Act request
The Health Research Council of New Zealand (HRC) received your email request for 
official information on 11 October 2021. You requested the following information under 
the Official Information Act 1982 (OIA):
In your "Update on COVID-19 clinical trials" dated 17 February 2021 you state:
"...all three clinical trials planned to include hydroxychloroquine in their evaluation of 
potential treatments for COVID-19, however given the rapidly emerging evidence on 
potential COVID-19 treatments from other international trials, all three trials have 
adapted significantly and have removed hydroxychloroquine as a candidate for 
treatment or prevention."


Can you please provide all the evidence from international trials and related 
documentation held or received by HRCNZ and/or related agencies that went into 
this hydroxychloroquine removal decision?

The HRC funded the three clinical trials (as indicated in your request) that initially 
included hydroxychloroquine as a potential COVID-19 treatment in their proposals. 
However, based on the evidence indicated below, all three trials removed 
hydroxychloroquine as a potential COVID-19 treatment from their proposals. 
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Page 2
The reasons provided to the HRC for making the decision to remove hydroxychloroquine 
as a potential COVID-19 treatment from their proposals are:
 Clinical trial of COVID-19 treatments for the critically ill (REMAP-CAP COVID)
Principal Investigator Dr Colin McArthur
Contact email: [email address]

Recruitment for the hydroxychloroquine-containing arms of the antiviral domain of 
REMAP-CAP COVID was paused in New Zealand pending publication of 
hydroxychloroquine data from the RECOVERY trial (refer Enrolment into the hydroxychloroquine and 
combination therapy arms was subsequently halted internationally based on external 
data from other clinical trials (for example, refer RECOVERY trial
Please note the following:
 Although it did not form part of the decision to stop randomisation to 
hydroxychloroquine at the time, when the futility trigger was met for the 
remaining intervention (lopinavir/ritonavir) in the antiviral domain, the results for 
the full domain were analysed and published, which demonstrated harm for the 
use of hydroxychloroquine in the trial’s critically ill population. This is strong 
evidence that the decision to stop was correct. Refer
 Australasian COVID-19 Trial (ASCOT)
Principal Investigator Dr Susan Morpeth
Contact email: [email address]

The initial ASCOT study protocol was designed as a factorial randomised clinical trial 
of hydroxychloroquine and lopinavir-ritonavir in the treatment of COVID-19. Both of 
these agents were withdrawn due to external data from other clinical trials. For 
example, refer to the SOLIDARITY trial 
) and 
the RECOVERY trial (
Please note the following:
 Equipoise was lost for most clinical trials of hydroxychloroquine once the 
RECOVERY trial reported no benefit with a trend toward harm. Subsequent 
publications (and unpublished studies) of hydroxychloroquine / chloroquine as 
summarised in this meta-analysis (
22446-z) confirmed the mortality haza
rd. RECOVERY and the WHO-led 
SOLIDARITY trial provided the greatest number of patients leading to this 
 ASCOT in New Zealand opened under a revised study protocol to align with its 
partnering Australian sites. Subsequently, the ASCOT protocol was amended to 

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transform it into ASCOT ADAPT, a platform trial with antiviral, antibody and 
anticoagulation domains.
 Clinical trial of hydroxychloroquine prophylaxis in frontline healthcare workers 
Principal Investigator Professor Richard Beasley
Contact email: [email address]

The clinical trial of the efficacy of a prophylactic weekly hydroxychloroquine regimen 
for frontline healthcare workers at high risk from SARS-CoV-2 infection was stopped 
before recruitment began due to the elimination of community transmission in New 
Zealand (2020), and concerns regarding the lack of efficacy and risks with 
hydroxychloroquine treatment in COVID-19. For example, refer to the SOLIDARITY 
trial (
) and the RECOVERY trial (
Please see above the contact details (email addresses) of the principal investigators of 
these three research studies, who have all agreed to answer any additional queries that 
you may have in this regard.
If you are not satisfied with our response, you have the right to seek an investigation and 
review by the Ombudsman of this decision. Information about how to make a complaint 
is available at or freephone 0800 802 602. 
Ngā mihi
Signed by: Sunny Collings 
Date & Time: 08 Nov, 2021 10:04:31 NZDT
Professor Sunny Collings
Tāhuhu Rangapū | Chief Executive