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Optimus announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir conducted in India

Optimus, Press Release, Oct 2021
Early treatmentRCT · 1,202 patients · India
Molnupiravir for COVID-19
Optimus Press Release · October 2021
Worse recovery and improved viral clearance
p = 0.027 (recovery) and p < 0.0001 (viral clearance)
RCT 1,202 patients showing improved viral clearance, but no significant differences in clinical outcomes. Only interim results were reported by the manufacturer, the final results are from1. Some results are provided only as percentages without confirming if data was available for all patients - we assume all patients had data available.
Potential risks of molnupiravir include the creation of dangerous variants, and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity2-16. Multiple analyses have identified variants potentially created by molnupiravir17-21. Studies show significantly increased risk of acute kidney injury22, cardiovascular toxocity23, and neurological symptoms22. Treatment may increase viral rebound24,25.
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OutcomeImprovementEffect · pTreatmentControl
risk of hospitalization 75.2% lower · RR 0.25 · p = 0.22 75.2% lowerRR 0.25p = 0.22 1 of 603 (0.2%) 4 of 599 (0.7%) treatment 1 of 603 (0.2%), control 4 of 599 (0.7%)NNT 199day 14
no 2-point ordinal scale improvement 15.5% higher · RR 1.15 · p = 0.03* 15.5% higherRR 1.15p = 0.03* 286 of 603 (47.4%) 246 of 599 (41.1%) treatment 286 of 603 (47.4%), control 246 of 599 (41.1%)day 28
no 2-point ordinal scale improvement 14.9% higher · RR 1.15 · p = 0.02* 14.9% higherRR 1.15p = 0.02* 303 of 603 (50.2%) 262 of 599 (43.7%) treatment 303 of 603 (50.2%), control 262 of 599 (43.7%)day 14
no 2-point ordinal scale improvement 8.7% lower · RR 0.91 · p = 0.09 8.7% lowerRR 0.91p = 0.09 308 of 603 (51.1%) 335 of 599 (55.9%) treatment 308 of 603 (51.1%), control 335 of 599 (55.9%)NNT 21day 10
no 2-point ordinal scale improvement 4.0% lower · RR 0.96 · p = 0.27 4.0% lowerRR 0.96p = 0.27 431 of 603 (71.5%) 446 of 599 (74.5%) treatment 431 of 603 (71.5%), control 446 of 599 (74.5%)NNT 34day 5
no 1-point ordinal scale improvement 27.7% higher · RR 1.28 · p = 0.80 27.7% higherRR 1.28p = 0.80 9 of 603 (1.5%) 7 of 599 (1.2%) treatment 9 of 603 (1.5%), control 7 of 599 (1.2%)day 28
no 1-point ordinal scale improvement 32.4% higher · RR 1.32 · p = 0.66 32.4% higherRR 1.32p = 0.66 12 of 603 (2.0%) 9 of 599 (1.5%) treatment 12 of 603 (2.0%), control 9 of 599 (1.5%)day 14
no 1-point ordinal scale improvement 87.8% lower · RR 0.12 · p < 0.001*** 87.8% lowerRR 0.12p < 0.001*** 13 of 603 (2.2%) 106 of 599 (17.7%) treatment 13 of 603 (2.2%), control 106 of 599 (17.7%)NNT 6.4day 10
no 1-point ordinal scale improvement 46.1% lower · RR 0.54 · p < 0.001*** 46.1% lowerRR 0.54p < 0.001*** 127 of 603 (21.1%) 234 of 599 (39.1%) treatment 127 of 603 (21.1%), control 234 of 599 (39.1%)NNT 5.6day 5
risk of no viral clearance 40.6% lower · RR 0.59 · p < 0.001*** 40.6% lowerRR 0.59p < 0.001*** 174 of 603 (28.9%) 291 of 599 (48.6%) treatment 174 of 603 (28.9%), control 291 of 599 (48.6%)mid-recoveryNNT 5.1day 5
risk of no viral clearance 0.7% lower · RR 0.99 · p = 1.00 0.7% lowerRR 0.99p = 1.00 7 of 603 (1.2%) 7 of 599 (1.2%) treatment 7 of 603 (1.2%), control 7 of 599 (1.2%)NNT 12900day 14
risk of no viral clearance 86.0% lower · RR 0.14 · p < 0.001*** 86.0% lowerRR 0.14p < 0.001*** 13 of 603 (2.2%) 92 of 599 (15.4%) treatment 13 of 603 (2.2%), control 92 of 599 (15.4%)NNT 7.6day 10

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates. * p < 0.05   *** p < 0.001

Optimus et al., 28 Oct 2021, Randomized Controlled Trial, India, preprint, 1 author, licensee.
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org November 2026 India Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines USA Brazil France Italy Canada Pakistan Spain Vietnam Japan Nepal Iran Bangladesh Ethiopia Ghana Germany Mexico South Korea United Kingdom Saudi Arabia Algeria Morocco Poland Thailand Uganda Egypt Nigeria Taiwan Fiji Zambia Bosnia-Herzegovina Dominican Republic Bolivia Côte d'Ivoire Eritrea Togo Bulgaria Greece Slovakia Iceland New Zealand Trinidad and Tobago Mongolia Czechia Belarus Israel North Macedonia Hong Kong Qatar Panama Serbia Benin Burundi Cameroon CAR India favored low-cost treatments.The average efficacy of treatments was moderate.Low-cost treatments improve early treatment, andprovide complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
$0 $500 $1,000+ Efficacy vs. cost for COVID-19treatment protocols worldwide c19early.org November 2026 India Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines USA Brazil France Italy Canada Pakistan Spain Vietnam Japan Iran Bangladesh Ethiopia Ghana Germany Mexico South Korea United Kingdom Saudi Arabia Algeria Morocco Yemen Poland Thailand Uganda Egypt Nigeria Taiwan Fiji Zambia Dominican Rep. Bolivia Côte d'Ivoire Eritrea Togo Sri Lanka Bulgaria Greece Slovakia New Zealand Trinidad and Tobago Mongolia Czechia Belarus Israel North Macedonia Hong Kong Qatar Panama Serbia Benin Burundi CAR Syria India favored low-cost treatments.The average efficacy was moderate.Low-cost protocols improve early treatment,and add complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%