Proactive anti-inflammatory therapy with colchicine in the treatment of advanced stages of new coronavirus infection. The first results of the COLORIT study
Mareev et al.
, Proactive anti-inflammatory therapy with colchicine in the treatment of advanced stages of new coronavirus..
, Kardiologiia, doi:10.18087/cardio.2021.2.n1560
Small trial with 21 colchicine patients and 22 control patients in Russia, showing improved recovery with treatment. The trial was originally an RCT, however randomization to the control arm was stopped after 5 patients, and 17 retrospective patients were added for comparison.
risk of death, 79.6% lower, RR 0.20, p = 0.49, treatment 0 of 21 (0.0%), control 2 of 22 (9.1%), NNT 11, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
ΔSHOCS-COVID, 50.0% lower, RR 0.50, p = 0.06, treatment 21, control 22, ΔSHOCS-COVID score, primary outcome.
SHOCS-COVID, 71.4% lower, RR 0.29, p = 0.002, treatment 21, control 22, SHOCS-COVID score.
NEWS-2, 66.7% lower, RR 0.33, p = 0.06, treatment 21, control 22, inverted to make RR<1 favor treatment, NEWS-2 score.
hospitalization time, 25.7% lower, relative time 0.74, p = 0.08, treatment 21, control 22.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Mareev et al., 28 Feb 2021, retrospective, Russia, peer-reviewed, 21 authors, dosage 1mg days 1-3.
Mareev V. Yu.1,2, Orlova Ya.A.1,2, Plisyk A.G.1,2, Pavlikova E.P.1,2,
Akopyan Z.A.1,2, Matskeplishvili S.Т.1, Malahov P. S.1, Krasnova T. N.1,2,
Seredenina E.M.1,2, Potapenko A.V.1,2, Agapov M.A.1,2, Asratyan D.A.1,
Dyachuk L.I.1,2, Samokhodskaya L. M.1,2, Mershina Е. А.1,2, Sinitsyn V. E.1,2,
Pakhomov P. V.2, Zhdanova E.A.1,2, Mareev Yu.V.3,4, Begrambekova Yu. L.1,2, Kamalov А. А.1,2
Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia
Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia
National Medical Research Centre for Therapy and Preventive Medicine, Moscow, Russia
Robertson Centre for Biostatistics, Glasgow, Great Britain
Proactive anti-inflammatory therapy
with colchicine in the treatment
of advanced stages of new coronavirus infection.
The first results of the COLORIT study
The course of the novel coronavirus disease (COVID-19) is unpredictable. In some cases, it manifests as
increasing inflammation that leads to a cytokine storm and irreversible progression to acute respiratory
syndrome, which is associated with the risk of death. Thus, proactive anti-inflammatory therapy
remains an open, serious question for patients with COVID-19 and pneumonia. This is especially true
for those patients who still have signs of inflammation on days 7–9 of the disease. These signs include
elevated C-reactive protein (CRP) >60 mg / dl and at least two of the four clinical signs: 1) fever
>37.5°C; 2) persistent cough; 3) dyspnea (RR >20 brpm) and / or reduced arterial oxygen saturation
(SaO2) <94 % when breathing atmospheric air. We designed the randomized trial: COLchicine versus
Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients with COVID-19
(COLORIT). We present here data comparing patients who received colchicine with those who did
not receive this specific anti-inflammatory therapy. Results of the comparison of colchicine, ruxolitinib,
and secukinumab will be presented later.
Compare efficacy and safety of colchicine in the management of patients with COVID-19 to that
without specific anti-inflammatory therapy.
Material and Methods
Initially, 20 people were expected to be randomized in the control group. However, enrollment to the
control group was discontinued after the inclusion of 5 patients due to the risk of severe deterioration
in the absence of anti-inflammatory treatment. Therefore, 17 patients, who had not received antiinflammatory therapy when previously treated in the MSU Medical Research and Educational Center,
were also included in the control group. The effects of treatment were assessed on day 12 after inclusion
or at discharge if discharge occurred earlier than on day 12. The primary endpoint was changes in the
SHOCS-COVID score, which includes an assessment of the patient’s clinical condition, CT score of
lung tissue damage, the severity of systemic inflammation as indicated by changes in CRP, and the risk
of thrombotic complications as indicated by D-dimer .
In the colchicine group, the median SHOCS score decreased from 8 to 2 (p=0.017), i.e., from a
moderate to a mild degree. In the control group, the change in the SHOCS-COVID score was minimal
and statistically insignificant. In patients treated with colchicine, CRP decreased rapidly from 99.4 and
normalized at 4.2 mg / dl (p<0.001). In the control group, CRP decreased moderately but..
is less effective
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