4 November 2021
Maxwell
Email: [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."
Source:
https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hrc.govt
.nz%2Fnews-events%2Fupdate-new-zealands-rapid-response-covid-19-clinical-
trials&data=04%7C01%7Cllon%40hrc.govt.nz%7Cf42979e3b5d142d9a09c08d
98c4ebd2d%7Cd8599fa25a0d4d6b8698ccfae7f9b041%7C0%7C0%7C6376950920
74450518%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2l
uMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=lrVp8SQ3WkKk
RuPDjJzfRtx8KOgxt70IpNKf%2BcHx2nU%3D&reserved=0
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.
Level 1, South Tower, 110 Symonds Street, Auckland 1010, New Zealand
PO Box 5541, Victoria Street West, Auckland 1142, New Zealand
+64 9 3035200
www.hrc.govt.nz
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]
https://www.hrc.govt.nz/resources/research-repository/clinical-trial-covid-19-
treatments-critically-ill
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
https://www.recoverytrial.net/). 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
https://www.recoverytrial.net/).
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
https://link.springer.com/article/10.1007%2Fs00134-021-06448-5
Australasian COVID-19 Trial (ASCOT)
Principal Investigator Dr Susan Morpeth
Contact email:
[email address]
https://www.hrc.govt.nz/resources/research-repository/australasian-covid-19-trial-
ascot
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
(https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-
on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments) and
the RECOVERY trial (
https://www.recoverytrial.net/).
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-anal
ysis (https://www.nature.com/articles/s41467-021-
22446-z) confirmed the mortality hazard. RECOVERY and the WHO-led
SOLIDARITY trial provided the greatest number of patients leading to this
conclusion.
ASCOT in New Zealand opened under a revised study protocol to align with its
partnering Australian sites. Subsequently, the ASCOT protocol was amended to
Page 3
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]
https://www.hrc.govt.nz/resources/research-repository/clinical-trial-
hydroxychloroquine-prophylaxis-frontline-healthcare
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 (
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-
research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-
treatments) and the RECOVERY trial
(https://www.recoverytrial.net/).
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 avail
able at www.ombudsman.parliament.nz 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
